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

NCT ID: NCT04987996

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2031-07-01

Brief 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.

Detailed Description

Eligible patients will be registered, stratified by diagnosis (melanoma versus OHN cancer), and the number of prior systemic therapies, and randomized to receive either GR-MD-02 + pembrolizumab or pembrolizumab + placebo.

In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.

Conditions

Metastatic Melanoma; Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GR-MD-02 + pembrolizumab

4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.

Group Type: EXPERIMENTAL

GR-MD-02

Intervention Type: DRUG

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

Pembrolizumab

Intervention Type: DRUG

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

Pembrolizumab Monotherapy

4 mg/kg placebo in combination with standard pembrolizumab treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Pembrolizumab

Intervention Type: DRUG

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

Interventions

GR-MD-02

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Pembrolizumab

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

Intervention Type: DRUG

Other Intervention Names

Galactoarabino-rhamnogalactouronate; Keytruda

Eligibility Criteria

Inclusion Criteria

• Patients with unresectable or metastatic melanoma including unknown primary, mucosal or uveal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers.
• Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible.
• Patients must be ≥ 18 years of age.
• ECOG performance status of 0-2.
• Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
• No active bleeding.
• Anticipated lifespan greater than 12 weeks.
• Patients must sign a study-specific consent document.

Exclusion Criteria

• Patients who have previously received a galectin antagonist.
• Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo (see Appendix C).
• Patients with history of autoimmune colitis.
• Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
• Patients requiring other systemic oncologic therapy, including experimental therapies.
• Patients with active infection requiring antibiotics.
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
• Need for steroids at greater than physiologic replacement doses. Inhaled corticosteroids are acceptable.
• Laboratory exclusions (to be performed within 28 days of enrollment):

• WBC < 3.0 x 109/L
• Hgb < 9.0 g/dL
• AST or ALT > 1.5 times ULN
• Total bilirubin > 1.9 g/dL, unless due to Gilbert's Syndrome. If Gilbert's Syndrome is present by clinical history, then direct bilirubin must by < 3.0 g/dl.
• Known history of HIV
• Known history of Hepatitis B
• Known history of Hepatitis C
• INR > 1.5x ULN
• Inability to give informed consent and comply with the protocol. Patients must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
• Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
• Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Cancer Center, Earle A. Chiles Research Institute

OTHER

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan D. Curti, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

Portland Providence Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

2020000655

Identifier Type: -

Identifier Source: org_study_id