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Monoclonal Antibodies

GB1211 + Pembrolizumab for Melanoma and Head & Neck Cancer

Phase 2

Recruiting

Led By Brendan D. Curti, MD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas with histological confirmation of melanoma by previous biopsy or cytology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 85

Awards & highlights

Study Summary

This trial will compare effectiveness of two drugs vs. just one in treating melanoma & head & neck cancer.

Who is the study for?

Adults with advanced melanoma or head and neck squamous cell carcinoma that's unremovable or has spread, and who have not responded to certain chemotherapies. They must be in a condition where they can live for at least another 12 weeks, agree to prevent pregnancy, and haven't had specific treatments that would exclude them.Check my eligibility

What is being tested?

The trial is testing the effectiveness of GB1211 combined with Pembrolizumab versus Pembrolizumab with a placebo in treating metastatic melanoma or head and neck cancer. The goal is to see which combination works better for these conditions.See study design

What are the potential side effects?

Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin issues, flu-like symptoms, and infusion-related reactions. GB1211 side effects are currently under study but could include similar immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have melanoma that cannot be removed by surgery or has spread, confirmed by a biopsy.

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I am not currently experiencing any bleeding.

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I have melanoma and have not received any treatment for it.

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My head/neck cancer got worse despite having platinum-based chemo.

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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate based on disease imaging

Secondary outcome measures

Evaluation of Antiviral Immunity

Evaluation of GAL-3 Expression

Evaluation of Predictive Biomarker

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GB1211 + PembrolizumabExperimental Treatment2 Interventions

GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment.

Group II: Pembrolizumab MonotherapyPlacebo Group2 Interventions

Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

GB1211

2019

Completed Phase 1

~100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor

117 Previous Clinical Trials

822,443 Total Patients Enrolled

10 Trials studying Melanoma

212 Patients Enrolled for Melanoma

Providence Cancer CenterUNKNOWN

1 Previous Clinical Trials

3 Total Patients Enrolled

Providence Cancer Center, Earle A. Chiles Research InstituteOTHER

18 Previous Clinical Trials

386 Total Patients Enrolled

4 Trials studying Melanoma

63 Patients Enrolled for Melanoma

Media Library

GB1211 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05913388 — Phase 2

Melanoma Research Study Groups: GB1211 + Pembrolizumab, Pembrolizumab Monotherapy

Melanoma Clinical Trial 2023: GB1211 Highlights & Side Effects. Trial Name: NCT05913388 — Phase 2

GB1211 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05913388 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new participants to join this experiment?

"No, this investigation does not currently require patients. This research was initially posted on August 1st 2023 and was recently updated on June 19th 2023. Despite this fact, there are still 3310 other clinical trials actively enrolling participants at the current moment."

Answered by AI

To what extent is GB1211 + Pembrolizumab safe for individuals?

"Our team's evaluation of the safety profile of GB1211 + pembrolizumab was a 2, as there is evidence for its security but no data yet to demonstrate efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

2024. "GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05913388.