Comparing GB1211 with Pembrolizumab to Pembrolizumab and Placebo for Advanced Melanoma and Head and Neck Cancer

Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

This study is testing whether adding a new drug called GB1211 to pembrolizumab can help people with advanced melanoma and head and neck cancer more than just using pembrolizumab alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Providence Health & Services (Academic / other)
• Drugs / interventions: chemotherapy, pembrolizumab
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT05913388 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of GB1211 in combination with pembrolizumab compared to pembrolizumab alone with a placebo in patients suffering from advanced metastatic melanoma and head and neck squamous cell carcinoma. Eligible participants will be stratified based on their specific diagnosis and prior treatment history before being randomized into one of the two treatment groups. The study will assess the objective response rates to these treatments, providing insights into their efficacy in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic melanoma or recurrent head and neck squamous cell carcinoma who have experienced disease progression after prior treatments.

Not a fit: Patients with early-stage melanoma or head and neck cancers that are resectable may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with advanced metastatic melanoma and head and neck squamous cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Patients with unresectable or metastatic melanoma including unknown primary or mucosal 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.
* 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 who have received anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose.
* Patients with Child-Pugh C hepatic impairment.
* 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.
  * Active or known history of HIV
  * Active or known history of Hepatitis B
  * Active or known history of Hepatitis C
  * Platelet counts \< 100 x 10E9 / L (100,000/ μL) without transfusion
  * 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.

Where this trial is running

Portland, Oregon

• Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)

Study contacts

• Principal investigator: Brendan D. Curti, MD — Providence Health & Services
• Study coordinator: Chris Fountain, RN, ONC

Conditions Metastatic Melanoma; Head and Neck Squamous Cell Carcinoma; metastatic melanoma; head and neck squamous cell carcinoma; pembrolizumab; galecto; GB1211