Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03650764
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramucirumab — DRUG
    Ramucirumab is an investigational agent for this trial and will be supplied by Lilly Oncology, free of charge to the patient
  • Pembrolizumab — DRUG
    Pembrolizumab is commercially available

Study Details

The investigators hypothesize that inhibition of angiogenesis and PD-1 will be more effective than inhibition of PD-1 alone. The first step in pursuing proof of this hypothesis is to establish the safety and feasibility of combining ramucirumab with pembrolizumab, therefore the first part of this protocol is a de-escalation phase I trial of the combination of ramucirumab + pembrolizumab. Three participants will be treated at each dose level. De-escalation to the next dose level will occur if 2 or more participants experience dose-limiting toxicities (DLTs) attributable to ramucirumab during cycle 1. The key objective of the phase I trial is to establish the safety and the recommended phase 2 dose (RP2D) of ramucirumab for this novel combination regimen in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM-HNSCC). The second step in pursuing proof of this hypothesis is to establish the efficacy of ramucirumab (using the RP2D) with pembrolizumab. The second part of this protocol is a single arm phase II trial combining ramucirumab + pembrolizumab. The primary objective of the phase II trial is to determine the tumor response rates (complete response (CR) and partial response (PR)) of the treatment combination given as first line therapy in patients with RM-HNSCC.

Key Dates

First listed
Aug 29, 2018
Start date
May 29, 2019
Status verified
Aug 2026
Primary completion
May 11, 2026
Completion
May 11, 2026

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Level 1 : Ramucirumab (10 mg/kg) + Pembrolizumab
    Participants enrolled in Phase I Dose Level 1 received 10 mg/kg ramucirumab administered intravenously (IV) on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.
  • Experimental: Phase II: Ramucirumab (10 mg/kg) + Pembrolizumab
    Participants enrolled in the Phase II portion received 10 mg/kg intravenous ramucirumab which was the recommended phase 2 dose (RP2D) determined during the Phase I portion on Day 1. Pembrolizumab was administered as per standard of care (SOC) IV at a dose of 200 mg on Day 1. Each cycle was 21 days.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) of Ramucirumab Combined With Fixed Dose Pembrolizumab (Phase I Participants Only) [ Time Frame: Completion of first cycle of treatment (each cycle is 21 days) for all participants enrolled in Phase I portion of study (estimated to be 2.5 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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