Metastatic Colorectal Cancer Clinical Trials (2023)

  • Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer Rochester, MN

    The purpose of this research study is to see if cancer will respond better to a combination of irinotecan and cetuximab with or without bevacizumab

  • A Study to Evaluate the Safety and Effectiveness of AB928-Based Treatment Combinations to Treat Patients with Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the clinical activity, safety and tolerabilityof etruma-based treatment combinations.

  • Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ

    This study seeks to evaluate the efficacy and tolerability of veliparib in combination with FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan. This is a blinded study such that the Investigator and Subject will be blinded but AbbVie will be unblinded.

  • Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Rochester, MN; Scottsdale/Phoenix, AZ

    This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid ...

  • A Global, Randomized, Placebo-controlled Phase 3 Study of Fruquintinib in Patients with Refractory Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to compare the effectivenessand safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

  • Patient Outcomes after Hepatic Artery Infusion Pump Placement Rochester, MN

    The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).

  • A Study to Evaluate the Combination of Binimetinib and Palbociclib in Treating Patients with KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Scottsdale/Phoenix, AZ

    The purose of this study is to determinehow well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib ...

  • S1406 A Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer Rochester, MN

    This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...

  • A Study Evaluating the Safety and Effectiveness of Therapies in Patients with Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study for the Inavo +Cetux Arm (A): To evaluate theeffectivenessof Inavo +Cetux in PIK3CA-mutated colorectal cancer (CRC) with no detected RAS (KRAS, NRAS) or BRAFV600E mutations.

    The purpose of this study for the Inavo +Bev Arm (B_: To evaluate the effectivenessInavo +Bev in PIK3CA-mutated, RAS (KRAS, NRAS)-mutated CRC.

    The purpose of this study for the Atezo+SY-5069 Arm (C): To evaluate the effectiveness of atezolizumab and SY-5609 treatment combination on patients with mCRC.

    (Video) Metastatic Colorectal Cancer: Clinical Trial Conversation

    The purpose of this study for the GDC-6036+cetuzimab+FOLFOX Arm (E):To evaluate the effectivenss of GDC-6036 plus cetuximab plus FOLFOX on patients with mCRC.

    The purpose of this study ...

  • A Study to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer No Locations

    The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151,nal-IRI,5-FU,and leucovorinfor the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.

  • Regorafenib in Metastatic Colorectal Cancer Rochester, MN

    The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

  • MC200404, Safety and Immunogenicity of PolyPEPI1018 Vaccine in the Treatment of Late-stage Metastatic Colorectal Cancer Rochester, MN

    The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, tolearn more about the side effects of combinationand to collect information on howcancer responds to this combination.

    PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.

    Participants will receive TAS-102 and PolyPEPI1018 which ...

  • MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) Scottsdale/Phoenix, AZ

    The primary purpose of this study for Step 1:

    • To determine the RP2D of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.

    The primary purpose of this study for Step 2:

    • To assess the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
  • TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill ...

  • A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Patients with Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.

    (Video) Clinical Trial for Metastatic Colorectal Cancer

  • A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR),has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...

  • COlorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑Controlled Phase-III STudy Rochester, MN

    To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy

  • A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

  • DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) Jacksonville, FL

    The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

  • Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ

    The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP).

  • A Study to Investigate the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease Jacksonville, FL; Rochester, MN

    The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.

  • Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

  • Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the effectiveness ofMRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

  • Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) No Locations

    In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...

  • Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

  • A Study to Evaluate Trifluridine/Tipiracil Combined with Bevacizumab vs Trifluridine/Tipiracil to Treat Patients with Refractory Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluatethe effectivenessand safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer (mCRC).

    (Video) Exploring colorectal cancer clinical trials - Mayo Clinic

  • Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to evaluatehow well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is: negative for RAS wild-type colorectal cancer and has spread to other places in the body, and/or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the ...

  • Pemigatinib to Treat Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.

  • Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase II trial studies how well atezolizumab and capecitabine with or without bevacizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Monoclonal antibodies, such as atezolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in treating ...

  • Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) Scottsdale/Phoenix, AZ; Rochester, MN; Rochester, MN

    In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.

  • A Study to Compare Trilaciclib versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer Rochester, MN

    This study aims toevaluatethe impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.

  • A Study to Assess a New Personalized Tool for Colorectal Cancer Peritoneal Disease Treatment Rochester, MN

    The objectives of this study are togenomically characterize patient-derived organoids (PDOs) and primary tissues from colorectal peritoneal cancer (CRC) disease, to evaluate the use of PDOs as a new personalized therapy selection tool for intraperitoneal therapy in CRC peritoneal disease, and to evaluate the use of PDOs as a new personalized therapy selection tool for systemic therapy in CRC peritoneal disease.

  • Phase II Single-arm Study of Tepotinib Combined with Cetuximab Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is toassess the preliminary anti-tumor activity, safety, and tolerability, and to explore the pharmacokinetics (PK) of tepotinib in combination with cetuximab in participants with RAS/BRAF oncogene wild-type left-sided metastatic colorectal cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition factor (MET) amplification.

  • A Study of Grapiprant and Pembrolizumab in Patients with Advanced or Progressive MSS Colorectal Cancer Scottsdale/Phoenix, AZ

    This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. The purpose of this studyis to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.

  • A Study to Evaluate Encorafenib Plus Cetuximab with/without Chemotherapy to Treat Metastatic Colorectal Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is toevaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).

  • Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery Scottsdale/Phoenix, AZ

    This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.

  • A Phase 1b/2 Study of Onvansertib (PCM-075) inCombination with FOLFIRI and Bevacizumab forSecond-Line Treatment of Metastatic Colorectal Cancerin Patients with a KRAS Mutation Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of thisstudy is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.

    (Video) Focusing on You: Clinical Trial for Metastatic Colon Cancer

  • Study of RP-6306 With FOLFIRI in Advanced Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

  • A Study to Evaluate Gevokizumab with Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers Scottsdale/Phoenix, AZ

    The purpose of this study is todetermine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.

  • A Study of Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) La Crosse, WI

    The purpose of this study is to evaluate the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

  • A Study of Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.

  • Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

  • A Study of a Personalized Neoantigen Cancer Vaccine Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

  • Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors Scottsdale/Phoenix, AZ

    The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).

  • Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of thesephase I/II trial studies is to analyzethe side effects and best dose of liposomal irinotecan and rucaparibwhen given together with fluorouracil and leucovorin calcium, and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body. Drugs used in chemotherapy, such as liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

  • A Study to Evaluate Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is todetermine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.

  • A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors.

  • MEDI5395 Advanced Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose for this study is to find out if MEDI5395 and durvalumab will work and be safe for the treatment of solid tumors.

    (Video) Colon Cancer Patient Talks About Clinical Trials

  • Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients with Advanced Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.

  • An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of BND-22 in Patients with Advanced Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase with subparts 1A (monotherapy BND-22), 1B (BND-22 in combination with pembrolizumab)and 1C (BND-22 in combination with cetuximab)followed by a dose expansion phase (part 2)

  • FAQs

    What percentage of cancer clinical trials are successful? ›

    Experimental Cancer Therapy Shows Success in More Than 70 Percent of Patients in Global Clinical Trials.

    Are there clinical trials for Stage 4 colon cancer? ›

    Research and clinical trials are a key part of the multidisciplinary team approach to colon cancer treatment at Johns Hopkins. Our researchers are national leaders in clinical trials for treatments addressing stage 4 metastatic colon cancers, as well as new techniques for identifying colon cancer recurrence.

    Can you beat metastatic colon cancer? ›

    Cure is not possible for most patients with metastatic colorectal cancer, although some patients who have limited involvement of distant organs (particularly restricted to the liver and/or lung) can be cured with surgery. For others, chemotherapy is the most appropriate option.

    What is the success rate of dostarlimab? ›

    Dostarlimab Demonstrates 100% Complete Response Rate in Subset of Patients with dMMR Rectal Cancer.

    Are clinical trials a last resort for cancer patients? ›

    The benefits of participating in a clinical trial vary by person: Participants gain earlier access to new treatment. In many cases trials aren't a last resort — they may be the first choice for patients without other treatment options. Participants often don't have to pay for experimental treatment or procedures.

    Should I participate in a cancer clinical trial? ›

    Joining a clinical trial is especially helpful if there are not any standard treatments for that stage of disease. Even though there is no guarantee that the new treatment will work, participating in a clinical trial offers hope. Clinical trials are designed to be as safe as possible for patients.

    How likely is it to beat stage 4 colon cancer? ›

    Stage 4 colon cancer is the most serious and highest stage. The 5-year survival rate for stage 4 colon cancer is just under 15%. This means that about 15% of people with a diagnosis of stage 4 colon cancer will be alive in 5 years. Remember that survival rates are just estimates, or educated guesses.

    What is the longest you can live with Stage 4 colon cancer? ›

    Stage IV colon cancer has a relative 5-year survival rate of about 14%. This means that about 14% of people with stage IV colon cancer are likely to still be alive 5 years after they are diagnosed. But you're not a number. No one, including your doctor, can tell you exactly how long you'll live.

    Why is surgery not an option for Stage 4 colon cancer? ›

    Colon cancer most often spreads to the liver, but it can also spread to other places like the lungs, brain, peritoneum (the lining of the abdominal cavity), or to distant lymph nodes. In most cases surgery is unlikely to cure these cancers.

    Can metastatic colon cancer go into remission? ›

    Background: Stage IV colorectal cancer is usually an incurable disease. However, patients with resectable metastases have 5-year disease-free survival rates of up to 30%. Even with primarily irresectable disease, cure can be achieved in patients who become operable after neoadjuvant treatment.

    How long can you live with stage 4 metastatic colon cancer? ›

    Metastases can occur in any organ. Treatment of stage IV colon cancer is mostly palliative and its median survival is reported to be approximately 9 months with best supportive care.

    What is the miracle drug for colon cancer? ›

    Pembrolizumab, a Merck checkpoint inhibitor, was given to patients in that experiment for up to two years. In around one-third to one-half of the patients, tumors shrunk or stabilized, and they survived longer. Tumors eliminated in 10% of those who took part in the study.

    Can dostarlimab cure all cancers 100%? ›

    Dostarlimab as a neoadjuvant therapy

    For the first time in history, a clinical trial reported 100% eradication of tumors with no recurrence of cancerous cells [11,21]. A positive response was seen in 12/12 patients (100%) (95% CI: 74–100), with complete elimination of the locally advanced tumor.

    When will dostarlimab be available? ›

    On August 17, 2021, the FDA approved dostarlimab-gxly (brand name Jemperli) for adult patients with mismatch repair-deficient recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

    Is dostarlimab available in USA? ›

    Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, and full approval in February 2023.

    How often are clinical trials successful? ›

    Only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval.

    When should you stop a clinical trial? ›

    Most clinical trials run as planned from beginning to end. But sometimes trials are stopped early. For example, the IRB and DSMB may stop a trial if the people taking part are having unexpected and severe side effects. Or they may stop a trial if there is clear evidence that the harms are greater than the benefits.

    Why do patients drop out of clinical trials? ›

    Why do patients drop out of clinical trials? The most common reasons patients give for dropping out fall into four categories – inconvenience and overwhelm, lack of communication, feeling underappreciated, and financial barriers.

    What is the downside of clinical trials? ›

    What are the Potential Risks of a Clinical Trial? The new treatment may cause serious side effects or be uncomfortable. The new treatment may not work, or it may not be better than the standard treatment.

    Are clinical trials worth the risk? ›

    Possible benefits

    Well-designed and well-performed clinical trials provide benefits to you while allowing you to help others by contributing to knowledge about new treatments or procedures. You gain access to new research treatments before they are widely available.

    What are the disadvantages of clinical trials? ›

    Potential Disadvantages of Participating in a Clinical Study
    • Treatment is not always effective.
    • Some patients may experience side effects.
    • Some patients may be given a placebo instead of the active new drug.
    • Patients may find treatments, hospital stays, and frequent trips to the study site to be demanding.

    Has anyone been cured of stage 4 colon cancer? ›

    Stage 4 colon CANcer free

    “Stage 4 colon cancer isn't always terminal,” Gupta says. “A proportion of patients, especially those with limited liver disease, do very well and can be potentially cured.”

    What is the life expectancy of colon cancer that has metastasized? ›

    If the cancer has spread to surrounding tissues or organs and/or the regional lymph nodes, the 5-year survival rate is 72%. If colon cancer has spread to distant parts of the body, the 5-year survival rate is 14%. For rectal cancer, the overall 5-year survival rate for people is 67%.

    What is the best medication for metastatic colorectal cancer? ›

    There are several different types of immunotherapy. The most important types for advanced colorectal cancer are the immune checkpoint inhibitors nivolumab (brand name: Opdivo), pembrolizumab (brand name: Keytruda), and ipilimumab (brand name: Yervoy).

    Is chemo worth it for stage 4 colon cancer? ›

    If the colon cancer has spread too far for surgery to be effective, chemotherapy is the primary treatment option. Most people with stage 4 colon cancer will receive chemotherapy or specific targeted therapies to help control the cancer progression or symptoms.

    What causes death in colon cancer patients? ›

    If your loved one is dying from colon cancer, they most likely have diffuse ​metastases . That means their cancer has spread from the colon to other organs and lymph nodes. Metastatic cancer often causes pain in the location where cancer has spread.

    What foods should you avoid with colon cancer? ›

    Avoid red meat and processed meats like hot dogs. Choose lean proteins like eggs, fish and poultry instead. Good plant-based sources of protein are lentils, nuts and legumes. Roughage, or fiber, is the fibrous, indigestible material part of plant-based foods that aid the passage of food through the intestines.

    Are metastatic cancers rarely fatal? ›

    In most cases, metastatic cancer is not curable. However, treatment can slow growth and ease many of the associated symptoms. It's possible to live for several years with some types of cancer, even after it has metastasized. Some types of metastatic cancer are potentially curable, including melanoma and colon cancer.

    How long can chemo prolong life with colon cancer? ›

    With cytotoxic therapy, the median overall survival (OS) was extended by approximately 4 months to 12 months, and the progression-free survival (PFS) was also prolonged to 6 months [3].

    How effective is Folfox for Stage 4 colon cancer? ›

    They noted that FOLFOX significantly increases the survival rate in people receiving at least eight cycles. A 2019 study compared FOLFOX with an alternative regimen called FOLFIRI in people with stage 4 colon cancer. The researchers found no significant differences in survival rates between the two treatments.

    Can you survive metastatic colorectal cancer? ›

    Among people diagnosed with metastatic colorectal cancer, approximately 70% to 75% of patients survive beyond 1 year, 30% to 35% beyond 3 years, and fewer than 20% beyond 5 years from diagnosis.

    Has anyone recovered from metastatic cancer? ›

    In the past, many people did not live long with metastatic cancer. Even with today's better treatments, recovery is not always possible. But doctors can often treat cancer even if they cannot cure it. A good quality of life is possible for months or even years.

    Does metastatic cancer always come back? ›

    Often, cancer recurrence is metastatic. An initial cancer that was stage 1 or stage 2 can recur in stage 4 with metastases. More than 90% of cancer deaths occur due to metastases. Cancer treatments are intended to prevent cancer cells from growing or persisting in the body.

    How fast does metastatic colon cancer spread? ›

    How fast does colon cancer spread? Colorectal cancer tends to spread to the liver and lungs 2 years after initial cancer surgery.

    Is metastatic colorectal cancer terminal? ›

    The very end-stage can be somewhat unpredictable in its onset. However, the five-year survival rate for stage IV (metastasizing) colon cancer is only 14%¹. Treatment can help you live longer and have a much better quality of life, but there is still no cure for end-stage colon cancer.

    Can you survive colon cancer that has spread to the liver? ›

    Richard Burkhart, a Johns Hopkins cancer surgeon and researcher, advancements in the treatment of liver tumors caused by colon cancer have improved survival rates drastically. In fact, 40-60 percent of patients treated for isolated colon cancer liver metastasis are still alive five years after treatment.

    What kills colon cancer cells naturally? ›

    Superfoods for fighting colon cancer
    • Beans and legumes. Beans and legumes are hailed as superfoods in the fight against colon cancer. ...
    • Berries. Berries are full of antioxidants and phytonutrients that are good for your health. ...
    • Carrots. ...
    • Coffee. ...
    • Cruciferous vegetables. ...
    • Nuts. ...
    • Spinach. ...
    • Foods with high glycaemic load.
    Jun 13, 2019

    What kills colon cancer stem cells? ›

    "The combination of resveratrol and grape seed extract is very effective at killing colon cancer cells," said Vanamala, who is also a faculty member at the Penn State Hershey Cancer Institute.

    How can I slow down colon cancer growth? ›

    Here are 6 ways to help protect your colorectal health.
    1. Get screened for colorectal cancer. Screenings are tests that look for cancer before signs and symptoms develop. ...
    2. Eat lots of vegetables, fruits, and whole grains. ...
    3. Get regular exercise. ...
    4. Take control of your weight. ...
    5. Don't smoke. ...
    6. Avoid alcohol.
    Feb 5, 2021

    Do clinical trials for cancer ever work? ›

    Today, people are living longer lives from successful cancer treatments that are the results of past clinical trials. Through clinical trials, doctors determine whether new treatments are safe and effective and work better than current treatments. Clinical trials also help us find new ways to prevent and detect cancer.

    What percentage of people drop out of clinical trials? ›

    Approximately 30% of patients drop out of clinical trials, resulting in heavy financial costs. On average, it costs $6,533 to recruit one patient to a clinical study, and the cost of replacing patients is even higher.

    How successful are clinical trials? ›

    Instead of less than 10% of drugs reaching the market, a new study has found that almost 15% of new compounds pass clinical trials – which still suggests that it is pretty tough.

    Why do cancer clinical trials fail? ›

    Ultimately, many oncology trials fail because they do not show a treatment extends survival in a meaningful way. For example, a drug tested in ocular melanoma, a rare cancer occurring in the eye, resulted in an eight-week improvement in progression-free survival. The study showed no difference in overall survival.

    Is it worth participating in clinical trials? ›

    Possible benefits

    Well-designed and well-performed clinical trials provide benefits to you while allowing you to help others by contributing to knowledge about new treatments or procedures. You gain access to new research treatments before they are widely available.

    What is the reason most clinical trials fail? ›

    For any failed trial, there can be many potential culprits for the failure. Sometimes these failures are unavoidable, but most of the time they arise due to poor planning or a misunderstanding of key biological and/or drug development principles.

    How often do clinical trials go wrong? ›

    Despite these significant investments in time and money, 90% of drug candidates in clinical trials fail. Whether because they don't adequately treat the condition they're meant to target or the side effects are too strong, many drug candidates never advance to the approval stage.

    What phase do most clinical trials fail? ›

    Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III.

    Do patients in clinical trials have better outcomes? ›

    Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at nonparticipating hospitals (low enrollment adjusted odds, 0.9 [95% CI, 0.8-1.0]; and high enrollment adjusted odds, 0.8 [95% CI, 0.7-0.9]).

    Do clinical trials save lives? ›

    Every day, new treatments help more people successfully fight cancer to live longer lives. Many of those patients have been saved because of clinical trials. Every medical breakthrough and cancer treatment started as a clinical trial.

    Are clinical trials trustworthy? ›

    Clinical studies in the United States are regulated by a government agency called the “Food and Drug Administration (FDA).” Each study is reviewed, approved, and watched over by an independent panel of qualified doctors, researchers, and members of the community called an “Institutional Review Board (IRB).” This review ...

    What are the most underfunded cancer research? ›

    Breast cancer, leukemia and lymphoma were consistently well-funded, whereas lung, colorectal, liver/biliary tract and uterine cancers were consistently underfunded.

    How long do cancer trials last? ›

    Phase I clinical trials each last several months to a year. They usually have 10 to 30 volunteers. The treatment might help the cancer. Also, information from the clinical trial may help other people in the future.

    Why is curing cancer so difficult? ›

    The difficulty in treating cancer is that it's not a single disease, but rather a group of diseases. In total there are more than 100 different types of cancers. Cancers are also caused by different things, so no one strategy can prevent them.

    Videos

    1. Drug That Helps Metastatic Colon Cancer of No Benefit in Less Advanced Tumors
    (Mayo Clinic)
    2. #15 | METASTATIC COLORECTAL CANCER-CLINICAL TRIALS in Florida | Cancer Education & Research Inst
    (CancerEdInstitute)
    3. Focusing on You: Clinical Trial for Metastatic Colon Cancer
    (University of Miami Health System)
    4. Colon Cancer Patient Talks About Clinical Trials
    (Johns Hopkins Medicine)
    5. Drug That Helps Metastatic Colon Cancer of No Benefit in Less Advanced Tumors
    (Mayo Clinic)
    6. Ongoing Clinical Trials in Colorectal Cancer
    (OncLiveTV)
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