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Monoclonal Antibodies

Ramucirumab + Pembrolizumab for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

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

Adequate blood and organ function as defined: Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 mg/dL; AST(SGOT) ≤ 3 x institutional upper limit of normal (IULN) and ALT(SGPT) ≤ 3 x IULN. In the setting of liver metastases, AST < 5 x IULN and ALT < 5 x IULN; Creatinine ≤ 2 x ULN OR creatinine clearance ≥ 40 mL/min/1.73 m2; Urine protein to creatinine ratio (UPC) ≤ 1; INR ≤ 1.5 x ULN (≤ 3.0 x ULN if on anticoagulation) and PTT ≤ 1.5 x ULN (<3 x ULN if on anticoagulation); Women of childbearing potential and men must agree to use adequate contraception

Performance status 0-2 (ECOG)

Must not have

Cirrhosis at a level of Child-Pugh B (or worse), Cirrhosis of any degree with a history of hepatic encephalopathy or clinically meaningful ascites; Receiving any other investigational agents

Receiving systemic steroid therapy (in dosing exceeding 20 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs to see if they are more effective than one of the drugs alone in treating head and neck cancer. The first part of the trial establishes the safety of the combination and the second part looks at its efficacy.

Who is the study for?

This trial is for adults with incurable head and neck squamous cell carcinoma (HNSCC) that can't be treated by surgery or radiation, or if the patient declines such treatments. Participants need to have certain blood counts and organ functions within specific ranges, no severe allergies to study agents, no recent heart attacks or strokes, and must not be pregnant. They should agree to use contraception and have not received certain therapies recently.

What is being tested?

The trial tests combining Ramucirumab with Pembrolizumab versus Pembrolizumab alone in treating HNSCC. Phase I determines the safe dose of Ramucirumab when combined with Pembrolizumab while phase II evaluates how effective this combination is as a first-line treatment by looking at tumor response rates.

What are the potential side effects?

Potential side effects include allergic reactions related to the drugs used, increased risk of bleeding or clotting issues due to angiogenesis inhibition (Ramucirumab), immune system-related side effects like inflammation from PD-1 inhibition (Pembrolizumab), fatigue, digestive problems, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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My head or neck cancer cannot be cured with surgery or radiation, or I cannot undergo these treatments.

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I am 18 years old or older.

Exclusion Criteria

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

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

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I haven't taken high-dose steroids or immunosuppressants in the last week.

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My blood pressure is not well controlled.

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I have an autoimmune disease treated with injections in the last 6 months.

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I have a history of GI issues like Crohn's disease or ulcerative colitis.

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I have side effects from cancer treatment that are mild, except for hair loss, tiredness, or skin issues.

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I am currently receiving radiation for brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall tumor response rate of ramucirumab and pembrolizumab (Phase II patients only)

Recommended phase 2 dose (RP2D) of ramucirumab combined with fixed dose pembrolizumab (Phase I patients only)

Secondary study objectives

Adverse event profile of the combination of ramucirumab and pembrolizumab (Phase I and II patients) as measured by the frequency of adverse events

Changes in quality of life as measured by EORTC QLQ-C30 (Phase II patients only)

Changes in quality of life as measured by FACT H&N (Phase II patients only)

+2 more

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973

46%

Fatigue

36%

Neutropenia

32%

Diarrhoea

30%

Decreased appetite

27%

Nausea

26%

Alopecia

24%

Dyspnoea

23%

Stomatitis

22%

Cough

22%

Anaemia

19%

Epistaxis

18%

Neutrophil count decreased

17%

Oedema peripheral

17%

Constipation

16%

Mucosal inflammation

16%

Pyrexia

14%

Lacrimation increased

14%

Vomiting

14%

Febrile neutropenia

13%

Myalgia

13%

Leukopenia

12%

Back pain

12%

Peripheral sensory neuropathy

11%

Headache

11%

Arthralgia

11%

Dysgeusia

11%

Insomnia

11%

Hypertension

11%

Asthenia

11%

Weight decreased

Abdominal pain

White blood cell count decreased

Pain in extremity

Oropharyngeal pain

Thrombocytopenia

Dizziness

Rash

Nail discolouration

Haemoptysis

Pain

Hyperglycaemia

Dyspepsia

Dehydration

Dysphonia

Paraesthesia

Productive cough

Pneumonia

Platelet count decreased

Bone pain

Chronic obstructive pulmonary disease

Hyponatraemia

Lobar pneumonia

Metastatic pain

Pleural effusion

Pneumothorax

Pulmonary embolism

Pulmonary haemorrhage

Syncope

Confusional state

Death

Atrial fibrillation

General physical health deterioration

Renal failure acute

100%

80%

60%

40%

20%

Study treatment Arm

Ramucirumab and Docetaxel

Placebo and Docetaxel

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

Group I: Phase II: Ramucirumab + PembrolizumabExperimental Treatment5 Interventions

-Patients will be treated with ramucirumab at the RP2D on Day 1 and SOC pembrolizumab (200 mg IV over 30 minutes) on Day 1 of each 21-day cycle.

Group II: Phase I: Ramucirumab + PembrolizumabExperimental Treatment3 Interventions

-Ramucirumab will be administered IV over 1 hour on Day 1 of each 21-day cycle. Pembrolizumab will be administered as per standard of care (IV at a dose of 200 mg over 30 minutes on Day 1 of each 21-day cycle). On Day 1, pembrolizumab will be given after ramucirumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral blood

2018

Completed Phase 2

~110

Ramucirumab

2017

Completed Phase 3

~5050