Treatment Clinical Trials for Rectal Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for rectal cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 26-50 of 53

  • HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1 / TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

    Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 has a better effect on these cancers than when they work alone. Objective: To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combined with M7824 causes a better immune response. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer (Phase I) or stage II or III p16-positive oropharyngeal cancer (Phase II) Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible photos of skin lesions CT, MRI, or nuclear bone scan: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may have a contrast agent injected into a vein. Participants may have up to 2 tumor biopsies. For participants in Phase II, this may be performed with a thin tube placed through the nose into the airway. Participants will receive the HPV vaccine alone or with M7824. For participants on the Phase II, they will receive two doses of HPV vaccine under the skin either alone or with M7824 as an infusion spaced two weeks apart. This will be done prior to their planned chemoradiation or surgery. For participants on the Phase I, they will get the HPV vaccine injected under the skin 2 to 3 times in the first month. Then they will have a booster every 4 weeks. They will receive M7824 as an infusion into a vein every 2 weeks. Treatment will last up to 1 year. After they stop treatment, participants will have a visit within 4 weeks. They will then be contacted for long-term follow-up every year, for the rest of their lives. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

    Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; P16+ oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers Design: Participants will be screened with: - medical history - disease confirmation (or tumor biopsy) - physical exam - body scans (CT, MRI, and / or nuclear) - blood tests - electrocardiogram (to measure the electrical activity of the heart) - urine tests. Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses. Participants will get M7824 by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period. Participants will get NHS-IL12 injected under the skin every 4 weeks. Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study. About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Heated Intra-peritoneal Chemotherapy with Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study

    This early phase I trial studies how well heated intra-peritoneal chemotherapy with doxorubicin and cisplatin work for the treatment of abdominal or pelvic tumors that can be removed by surgery (resectable), does not respond to treatment (refractory), or has come back (recurrent). Heated intra-peritoneal chemotherapy is a procedure performed in combination with abdominal surgery for cancer that has spread to the abdomen. It involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Drugs used in chemotherapy, such as doxorubicin and cisplatin, 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. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more cells.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Comparing Length of Treatment with Immunotherapy in Patients with Advanced Solid Tumors

    This phase III trial compares 1 year immunotherapy treatment versus continuous immunotherapy treatment beyond 1 year in patients with solid tumors that have spread to other places in the body (advanced). Immunotherapy such as pembrolizumab, nivolumab, atezolizumab, durvalumab, and avelumab are drugs given through a vein to the entire body to activate the immune system. Comparing the treatment lengths may help doctors determine the ideal length of time for treatment with immunotherapy in patients with solid tumors.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • KRAS Peptide Vaccine, Nivolumab, and Ipilimumab for the Treatment of Resected Pancreatic Cancer or MSS Colorectal Cancer

    This phase I trial is to find out the possible benefits and / or side effects of KRAS peptide vaccine, nivolumab, and ipilimumab in treating patients with pancreatic cancer or microsatellite-stable (MSS) colorectal cancer that has been removed by surgery (resected). KRAS peptide vaccine is a vaccine that is made up small pieces (peptides) of abnormal (mutated) KRAS protein. This abnormal protein may cause cancer cells to grow and spread in the body. Giving this vaccine may teach the body’s immune system to recognize and stop cancer cells with mutant KRAS. Nivolumab is an anti-PD-1 antibody that works by attaching to and blocking a molecule called PD-1, a protein that is present on different types of cells in the immune system that controls parts of it by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Ipilimumab is an anti-CTLA-4 antibody that works by attaching to and blocking a molecule called CTLA-4, a protein that is present on different types of cells in the immune system and controls parts of it by shutting it down. Antibodies that block CTLA-4 can potentially prevent CTLA-4 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Giving KRAS peptide vaccine, nivolumab, and ipilimumab may kill more tumor cells.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • Encorafenib, Cetuximab, and Nivolumab in Treating Patients with Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

    This phase I / II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Radiation Therapy and Chemotherapy in Treating Patients with Stage I-IIIB Rectal Cancer

    This phase II trial studies how well patients with stage I-IIIB rectal cancer respond to a short course of radiation therapy followed by chemotherapy. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and 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. A combination of radiation therapy and chemotherapy may prevent patients from needing surgery, could delay their need for surgery, or may mean that they need less drastic surgery and could potentially avoid a permanent ostomy (a surgically created connection between the intestine and the abdominal wall that allows for elimination of stool).
    Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri

  • M7824 in Subjects With HPV Associated Malignancies

    Background: In the United States, each year there are more than 30,000 cases of human papillomavirus (HPV) associated cancers. Some of these cancers are often incurable and are not improved by standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a pathway that prevents the immune system from effectively fighting the cancer can shrink tumors in people with some HPV cancers. Objectives: To see if the drug M7824 causes tumors to shrink. Eligibility: Adults age 18 and older who have a cancer associated with HPV infection. Design: Participants will be screened with medical history and physical exam. They will review their symptoms and how they perform normal activities. They will have body scans. They will give blood and urine samples. They will have a sample of their tumor tissue taken if one is not available. Participants will have an electrocardiogram to evaluate their heart. Then they will get the study drug through a thin tube in an arm vein. Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course. After the course, participants will be monitored but will not take the study drug. If their condition gets worse, they will start another course with the drug. This process can be repeated as many times as needed. Treatment will stop if the participant has bad side effects or the drug stops working. Throughout the study, participants will repeat some or all the screening tests. After participants stop taking the drug, they will have a follow-up visit and repeat some screening tests. They will get periodic follow-up phone calls. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Chemotherapy (mFOLFOX) and Short-Course Radiotherapy for the Treatment of Resectable Rectal Cancer

    This phase II trial studies the effect of 3 standard chemotherapy drugs before surgery (neoadjuvant), a shorter course of radiation therapy, and either monitoring (active surveillance) or surgery in treating patients with rectal cancer that can be removed by surgery (resectable). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and, leucovorin 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 photons / protons to kill tumor cells and shrink tumors. Giving chemotherapy before radiation therapy may kill more tumor cells, compared to the standard approach for treating patients with rectal cancer.
    Location: 2 locations

  • Early Effects of Chemotherapy and Radiation Therapy before Surgery for the Treatment of Localized Rectal Cancer

    This phase II trial investigates the early effects of chemotherapy and radiation therapy before surgery in treating patients with rectal cancer that is restricted to the site of origin, without evidence of spread (localized). Chemotherapy and radiation therapy are standard treatments that are given currently as part of rectal cancer management. Collecting tumor samples before and after standard treatment may allow researchers to better understand the outcomes following treatments with different frequencies of radiation and / or chemotherapy.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Short-Course Radiation Therapy and Combination Chemotherapy for the Treatment of Rectal Cancer, SHORT-FOX Study

    This phase II trial studies the effect of short-course radiation therapy and combination chemotherapy in treating patients with rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI), 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 short-course radiation therapy and FOLFOXIRI may increase the chance of the tumor completely going away, and ultimately lead to omission of surgery in patients with rectal cancer.
    Location: Stanford Cancer Institute Palo Alto, Palo Alto, California

  • Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer

    This phase I trial studies the side effects and best dose of regorafenib when given together with ipilimumab and nivolumab in treating patients with microsatellite stable colorectal cancer that has spread to other places in the body (metastatic) and remains despite chemotherapy treatment (resistant). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib, ipilimumab and nivolumab may slow the tumor growth and / or shrink the tumor size in patients with colorectal cancer.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California

  • A Study of Select Drug Combinations in Adult Patients With Advanced / Metastatic BRAF V600 Colorectal Cancer

    A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
    Location: 2 locations

  • Oxaliplatin and mFOLFIRI Regimen for the Treatment of Unresectable Peritoneal Carcinomatosis from Colorectal or Appendiceal Cancer

    This phase I trial identifies the best dose, the side effects and effectiveness of giving oxaliplatin in combination with a standard chemotherapy regimen (modified fluorouracil, leucovorin and irinotecan [mFOLFIRI]) for the treatment of colorectal or appendiceal cancer that has spread throughout the peritoneal cavity (peritoneal carcinomatosis) and cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and irinotecan work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving oxaliplatin in combination with fluorouracil, leucovorin, and irinotecan may work better than current standard therapies for the treatment of patients with peritoneal carcinomatosis and may improve survival outcomes.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • TAS-102 with Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer

    This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). 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. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • M7824 in Treating Patients with Metastatic or Unresectable Color or Rectal Cancer with Microsatellite Instability

    This phase Ib / II trial studies how well anti-PD-L1 / TGFbetaRII fusion protein M7824 (M7824) works in treating patients with colorectal cancer that has spread to other places in the body or cannot be removed by surgery with microsatellite instability. Immunotherapy with monoclonal antibodies, such as M7824, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy before Surgery in Treating Patients with Locally Advanced or Metastatic Rectal Cancer

    This phase I trial studies the best dose and side effects of talimogene laherparepvec in combination with 5-fluorouracil, leucovorin, oxaliplatin, capecitabine, and chemoradiation before surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue and lymph nodes. Drugs used in immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune system to fight tumor cells. Drugs used in chemotherapy, such as 5-fluorouracil, leucovorin, oxaliplatin, and 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving talimogene laherparepvec, 5-fluorouracil, leucovorin, oxaliplatin, and capecitabine and chemoradiation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer

    This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.
    Location: 2 locations

  • Universal Donor Natural Killer Cells and ALT-803 in Treating Patients with Relapsed or Refractory Blood Cancer, Colon / Rectal Cancer, or Soft Tissue Sarcoma

    This phase I trial studies the best dose of universal donor natural killer cells when given together with superagonist interleukin-15:interleukin-15 receptor alphaSu / Fc fusion complex ALT-803 (ALT-803) in treating patients with blood cancer, colon / rectal cancer, or soft tissue sarcoma that has come back after a period of improvement (recurrent) or does not respond to treatment (refractory). Natural killer cells are a type of white blood cell that may kill tumor cells. ALT-803 may enhance natural killer cell survival and enable them to increase in number after infusion. Giving natural killer cells and ALT-803 may kill more tumor cells.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Niclosamide in Treating Patients with Colon Cancer That Can Be Removed by Surgery

    This phase I trial studies the side effects of niclosamide in treating patients with colon cancer that can be removed by surgery. Niclosamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: Duke University Medical Center, Durham, North Carolina

  • Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

    Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer

    This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II / III rectal cancer, or Stage II (high risk) / Stage III colon cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers

    We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally. STUDY OBJECTIVE To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS) Primary endpoints - DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups); - DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer). Secondary endpoints - Overall survival (OS) over 5 years - DFS and OS in - Chinese, Malay, Indian and other ethnic groups - Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually - Compliant versus non-compliant subjects - PIK3CA mutated tumors (where samples are available)
    Location: See Clinical Trials.gov

  • Phase I / II Trial of the Combination of Bintrafusp Alfa (M7824), Entinostat and NHS-IL12 (M9241) in Patients With Advanced Cancer

    Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with NHS-IL12 and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and / or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get NHS-IL12 as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Testing Nivolumab and Ipilimumab with Short-Course Radiation in Advanced Rectal Cancer

    This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
    Location: Location information is not yet available.