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Compares treatment options for Metastatic Melanoma
Official title GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05913388
What this study is testing
What is GB1211?
GB1211 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be...
- 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...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- No active bleeding.
- Anticipated lifespan greater than 12 weeks.
- Patients must sign a study-specific consent document.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.