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

NCT04987996 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2020000655
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma; Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC; MM; pembrolizumab; GR-MD-02; Galectin Inhibitor; GRMD-02; GRMD002

Outcome Measures

Primary Outcomes (1)

• Overall response rate based on disease imaging

  Determine the objective response of GR-MD-02 + pembrolizumab versus pembrolizumab monotherapy in patients with advanced MM or HNSCC

  From date of randomization until the date of first documented progression, assessed up to 63 weeks.

Secondary Outcomes (6)

• Evaluation of GAL-3 expression

  Screening and Day 68

• Evaluation of predictive biomarker

  Day 85

• Frequency of Immune-mediated adverse events

  From time of informed consent to week 63

• Evaluation of antiviral immunity

  Day 85

• Evaluation of antiviral immunity

  Day 85

Study Arms (2)

GR-MD-02 + pembrolizumab

EXPERIMENTAL

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

Drug: GR-MD-02; Drug: Pembrolizumab

Pembrolizumab Monotherapy

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Pembrolizumab

Interventions

GR-MD-02 DRUG

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

Also known as: Galactoarabino-rhamnogalactouronate

GR-MD-02 + pembrolizumab

Placebo DRUG

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

Pembrolizumab Monotherapy

Pembrolizumab DRUG

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

Also known as: Keytruda

GR-MD-02 + pembrolizumab; Pembrolizumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Providence Health & Services: lead
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma; Squamous Cell Carcinoma of Head and Neck

Interventions

belapectin; pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms

Study Officials

• Brendan D. Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 3, 2021
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

US (1)