A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Yana Najjar
Study ID
NCT03311308
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Melanoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab Injection [Keytruda] — DRUG
    200mg, IV, every three weeks, up to two years; After the first three doses, dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
  • Metformin — DRUG
    500 mg, by mouth, twice a day for nine weeks.

Study Details

The purpose of this study is to evaluate the effectiveness and safety of the combination of Pembrolizumab (KEYTRUDA®) and the investigational drug, Metformin.

Key Dates

Start date
Feb 7, 2018
Status verified
May 2025
Primary completion
Jan 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pembrolizumab
    Pembrolizumab (Keytruda), 200 mg, by IV, every three weeks, for up to 2 years; after the first three doses, dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
  • Experimental: Pembrolizumab and Metformin Combination
    Pembrolizumab (Keytruda), 200mg, by IV, every three weeks, for up to 2 years will be taken in combination with Metformin, 500mg, twice a day, for nine weeks; after the first three doses, pembrolizumab dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.

Primary Outcome Measure

Ki-67 proliferation index in T cell [ Time Frame: up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univ of Pittsburgh Medical Center Hillman Cancer CenterPittsburghPennsylvania15232
Amy Rose, RN
412-647-8587

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By research site
Univ of Pittsburgh Medical Center Hillman Cancer Center· Pittsburgh, PA

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