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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.

Must not have

PD-L1 negative (CPS 0) disease, based on local IHC assay using 22C3 antibody.

Cutaneous or nasopharynx SCC.

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer does not show PD-L1 based on a specific test.

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My cancer is in the skin or nasopharynx.

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I haven't had major surgery in the last 4 weeks or minor surgery in the last week.

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I have received radiation to ease symptoms within the last 2 weeks.

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I haven't had any serious wounds, ulcers, or bone fractures in the last 28 days.

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My liver disease is severe, with complications like swelling or confusion.

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I haven't had any serious illnesses or conditions in the last 3 months that would stop me from following the study's requirements.

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I have not had a GI perforation or fistula in the last 6 months.

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I have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.

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I haven't had a heart attack, stroke, or major blood clot in the past 6 months.

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I have not had severe bleeding in the last 3 months.

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I am on daily medication for blood thinning, but only take aspirin up to 325 mg/day.

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I haven't had any recent bleeding or conditions that increase my risk of bleeding.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time criteria is met for cr or pr through completion of treatment (estimated to be 1 year and 40 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Duration of Response (DoR)

Incidence rate, frequency, and severity of adverse events (AEs)

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2810