A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05634577
Phase
PHASE2
Status
Terminated

Conditions

  • Adrenocortical Carcinoma

Eligibility Criteria

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

Interventions

  • Mitotane — DRUG
    Given by PO
  • Pembrolizumab — DRUG
    Given by vein (IV)

Study Details

To learn if adding pembrolizumab to mitotane can help to control ACC. The safety of this drug combination will also be studied.

Key Dates

Start date
Mar 23, 2023
Status verified
Jun 2025
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lead-in Phase
    Participants will first have a Lead-in Phase in which participants receive only mitotane. This will be 4 weeks long in most participants. Participants will then begin receiving pembrolizumab.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From time of active itervention (Combination therapy) ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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