GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients

NCT04987996 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-06

No results posted yet for this study

Summary

The purpose of this study is to test the safety \& efficacy of combination drugs versus placebo to treat metastatic melanoma and head and neck squamous cell carcinoma.

Conditions

Interventions

DRUG

GR-MD-02

Patients will receive up to seventeen doses of GR-MD-02 intravenously over 85 Days.

DRUG

Placebo

Patients will receive up to seventeen doses of placebo intravenously over 85 Days.

DRUG

Pembrolizumab

Patients will receive 200mg doses of pembrolizumab intravenously over 85 Days.

Sponsors & Collaborators

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER
  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Brendan D. Curti, MD · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2027-07-01
Completion
2031-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987996 on ClinicalTrials.gov