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Nivolumab + Relatlimab for Colorectal Cancer
Study Summary
This trial will test a new cancer treatment involving two drugs, nivolumab and relatlimab, in patients with colorectal cancer that has spread or is advanced and does not have changes in specific genes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I currently have an infection.I cannot have blood drawn for medical reasons.I am fully active or can carry out light work.I have been treated with specific immune therapies before.I have not taken any chemotherapy drugs in the last 4 weeks.I have been diagnosed with an immune system disorder.I need extra oxygen every day.I had surgery to remove my primary tumor.I have undergone at least one chemotherapy treatment.I have tissue samples from my initial cancer surgery available.My colorectal cancer is advanced but not responsive to immunotherapy.My primary cancer lesion has a high PD-L1/Mucin score.My cancer's PD-L1/Mucin score is below 15%.You are willing to undergo a procedure to collect a sample of your tumor for testing.You are expected to live for at least 3 more months.I have had a tissue, organ, or bone marrow transplant from another person.I have brain metastases but they've been stable for 4 weeks, I haven't used steroids in the last week, and there are no new or growing tumors.I have a serious health condition that is not under control.You have a current or suspected autoimmune disease.I do not have HIV or hepatitis B or C.I have a history of lung scarring or fibrosis.I need extra oxygen every day.I have a serious heart condition.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding.I am 18 years old or older.My organ and bone marrow functions meet the study's requirements.I haven't had chemotherapy, radiation, or steroids in the last 14 days.I need treatment to stop my cancer cells from growing.
- Group 1: Cohort A/B: Nivolumab and Relatlimab
- Group 2: Cohort C: Nivolumab and Relatlimab
- Group 3: Cohort C: Nivolumab and Relatlimab (co-administration)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What ailments does Relatlimab generally target?
"Relatlimab is frequently administered to patients with malignant neoplasms. It can also be beneficial for those struggling with metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanomas."
Has this trial been previously attempted in any similar formats?
"Research into Relatlimab initiated in 2012 when Ono Pharmaceutical Co. Ltd. launched a trial featuring 659 participants. After successfully passing Phase 1 & 2 clinical trials, today there are 719 active studies involving 2357 cities and 49 countries around the world."
What is the enrollment quota for this research experiment?
"Affirmative, according to information supplied on clinicaltrials.gov, this medical study is currently recruiting volunteers. Initially posted in February 2019, the trial has recently been updated and seeks 96 patients from 2 distinct locations."
Are there any openings for participation in this study currently?
"Based on the information found on clinicaltrials.gov, this survey is still looking for participants and was last updated in March of 2022. It has been posted since February 2019."
Is there any potential harm associated with taking Relatlimab?
"Gleaned from the data we have, Relatlimab's safety was scored a 2 on our scale; this is due to it being in Phase 2 trials with some evidence of security but no evidence for efficacy."
Has Relatlimab been the subject of previous experiments?
"At present, there are 82 Phase 3 clinical trials in progress for Relatlimab and 719 studies ongoing from around the world. Of these, many originate in Basel, BE; yet over forty-thousand other sites have contributed to Relatlimab research."
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