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PD-1 Inhibitor
Ramucirumab + Pembrolizumab for Head and Neck Cancer (Rambro2 Trial)
Phase 2
Recruiting
Led By Douglas R Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Incurable RM-HNSCC, defined as RM disease or second or subsequent primary HNSCC not amenable to cure by surgery and/or radiation therapy or patient declines or is ineligible for curative therapy. Eligible primary tumor sub-sites include oral cavity, oropharynx, larynx and hypopharynx only.
PD-L1 positive (CPS ≥1) disease, based on local IHC assay using 22C3 antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time criteria is met for cr or pr through completion of treatment (estimated to be 1 year and 40 weeks)
Awards & highlights
Rambro2 Trial Summary
This trial looks at combining a drug that targets VEGFR-2 with a PD-1 inhibitor to see if it works better than just the PD-1 inhibitor.
Who is the study for?
Adults with PD-L1 positive head and neck squamous-cell carcinoma, who haven't had systemic therapy for recurrent/metastatic cancer. They must have measurable disease, be in good physical condition (ECOG 0-1), have normal organ/blood function, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with negative PD-L1 status, recent surgeries or significant bleeding events, other cancers within a year (except certain skin cancers), serious illnesses or uncontrolled hypertension.Check my eligibility
What is being tested?
The trial is testing the combination of Ramucirumab (a VEGFR-2 inhibitor) and Pembrolizumab versus Pembrolizumab alone in treating patients. It's a phase 2 study aimed at seeing if adding Ramucirumab can boost the effectiveness of Pembrolizumab in this type of cancer.See study design
What are the potential side effects?
Possible side effects include high blood pressure from Ramucirumab; both drugs may cause immune-related reactions affecting organs like lungs or intestines, fatigue, infusion reactions related to drug administration into the vein, potential bleeding risks due to anti-blood vessel growth properties.
Rambro2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My head or neck cancer cannot be cured with surgery or radiation.
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My cancer is PD-L1 positive.
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My cancer can be measured by scans or physical exam.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My liver enzymes are within the required range.
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I agree to use birth control during and up to 28 days after the study.
Rambro2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time criteria is met for cr or pr through completion of treatment (estimated to be 1 year and 40 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time criteria is met for cr or pr through completion of treatment (estimated to be 1 year and 40 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DoR)
Incidence rate, frequency, and severity of adverse events (AEs)
Overall Survival (OS)
+1 moreRambro2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Ramucirumab and PembrolizumabExperimental Treatment2 Interventions
Patients receive ramucirumab IV and pembrolizumab IV every 3 weeks. Cycles are 21 days in length. Treatment will continue until progression or unacceptable toxicity for up to 35 cycles of treatment.
Group II: Arm 2: Pembrolizumab monotherapyActive Control1 Intervention
Patients receive pembrolizumab IV every 3 weeks. Cycles are 21 days in length. Treatment will continue until progression or unacceptable toxicity for up to 35 cycles of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,623 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,527 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently receiving radiation for brain metastases but finished it at least 2 weeks ago.I am fully active or can carry out light work.I haven't taken high doses of steroids or strong immune-weakening drugs in the last week.My blood pressure has been high (>160/100 mmHg) despite treatment in the last month.I haven't had a heart attack, stroke, or major blood clot in the past 6 months.I am on daily medication for blood thinning, but only take aspirin up to 325 mg/day.My kidney function, measured by creatinine levels, is within the normal range or adequately compensated.My cancer can be measured by scans or physical exam.I haven't needed strong medication for an autoimmune disease in the last 6 months.I haven't had any recent bleeding or conditions that increase my risk of bleeding.I agree to use birth control during and up to 28 days after the study.I haven't had any serious wounds, ulcers, or bone fractures in the last 28 days.My liver disease is severe, with complications like swelling or confusion.My cancer does not show PD-L1 based on a specific test.My cancer is in the skin or nasopharynx.I haven't had major surgery in the last 4 weeks or minor surgery in the last week.I had cancer other than skin cancer less than a year ago, but it's unlikely to come back.I haven't had any serious illnesses or conditions in the last 3 months that would stop me from following the study's requirements.I am 18 years old or older.My blood clotting levels are within the required range.My cancer is PD-L1 positive.I haven't had systemic therapy for my head and neck cancer, but I'm eligible if my disease worsened within 6 months after certain treatments.My blood tests for bone marrow and organ function are normal.My liver enzymes are within the required range.I have received radiation to ease symptoms within the last 2 weeks.You are currently taking any other experimental medications.You have had severe allergic reactions to drugs similar to Ramucirumab or other drugs used in the study.I have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.I have not had a GI perforation or fistula in the last 6 months.My head or neck cancer cannot be cured with surgery or radiation.I don't have severe side effects from previous cancer treatments, except for hair loss, low red blood cells, dry mouth, tiredness, or skin rash.I have not had severe bleeding in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Pembrolizumab monotherapy
- Group 2: Arm 1: Ramucirumab and Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings for this experiment?
"According to the information posted on clinicaltrials.gov, this particular medical study is no longer recruiting candidates. The trial was first announced on October 31st 2023 and received its last update on July 30th 2023. However, there are presently 3794 other trials actively searching for participants across the world."
Answered by AI
Has the combination of Ramucirumab and Pembrolizumab been sanctioned by the Food & Drug Administration?
"Our team at Power rated Arm 1: Ramucirumab and Pembrolizumab with a 2 for safety as this is only in Phase 2, which confirms some evidence of its security but none to demonstrate efficacy."
Answered by AI
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