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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT05913388
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GB1211 — DRUG
    Administered orally twice daily at 100mg.
  • Pembrolizumab — DRUG
    Administered at a fixed dose of 200 mg every 3 weeks intravenously.
  • Placebo — DRUG
    Administered orally twice daily at 100mg.

Study Details

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.

Key Dates

Start date
Feb 29, 2024
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GB1211 + Pembrolizumab
    GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment.
  • Placebo Comparator: Pembrolizumab Monotherapy
    Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment.

Primary Outcome Measure

Overall response rate based on disease imaging [ Time Frame: From the date of randomization until the date of first documented progression, assessed up to 63 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97213
Chris Fountain, RN
[email protected]
503-215-2691
Brendan D. Curti, MD (PRINCIPAL_INVESTIGATOR)
Rom S. Leidner, MD (SUB_INVESTIGATOR)
Matthew Taylor, MD (SUB_INVESTIGATOR)
William L. Redmond, PhD (SUB_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Head and neck cancerMelanoma
By specialty
OncologyENTSkin cancerDermatology
By research site
Providence Portland Medical Center· Portland, OR

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