A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

Part of paid clinical trials in Los Angeles, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT04854434
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Participants will receive selinexor oral tablets.
  • Pembrolizumab — DRUG
    Participants will receive pembrolizumab intravenously.
  • Trifluridine — DRUG
    Participants will receive trifluridine oral tablets as SOC.
  • Tipiracil — DRUG
    Participants will receive tipiracil oral tablets as SOC.

Study Details

The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care \[Combination of trifluridine and tipiracil\]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (\<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.

Key Dates

Start date
Jun 29, 2021
Status verified
Oct 2023
Primary completion
Jun 24, 2022
Completion
Jun 24, 2022

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Selinexor 80 mg
    Participants received a single dose of selinexor 80 mg (4 tablets of 20 mg) orally QW on Day 1 of each week of a 42-day cycle (i.e., on Days 1, 8, 15, 22, 29, and 36 of each 42-day cycle) until PD, intolerable toxicity, or withdrawal from the study (maximum exposure: 33 weeks).
  • Experimental: Arm B: Selinexor 80 mg and Pembrolizumab 400 mg
    Participants received a single dose of selinexor 80 mg (4 tablets of 20 mg) orally QW on Day 1 of each week of a 42-day cycle (i.e., on Days 1, 8, 15, 22, 29, and 36 of each 42-day cycle) in combination with pembrolizumab 400 mg IV once every 6 weeks of each 42-day cycle until PD, intolerable toxicity, or withdrawal from the study (maximum exposure: 30 weeks).
  • Active Comparator: Arm C: Standard of care (SOC)
    Participants received combination of trifluridine and tipiracil 35 mg/m\^2/dose tablets orally BID (maximum 80 mg per dose) as SOC on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until PD, intolerable toxicity, or withdrawal from the study (maximum exposure: 11 weeks).

Primary Outcome Measure

Arm B and C: Progression-free Survival (PFS) as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: From the date of randomization until disease progression or death, whichever occurs first (up to 8 months) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Christiana Care Health Services, Christiana HospitalNewarkDelaware19718-
BRCR GlobalPlantationFlorida33322-

Find similar trials in Los Angeles, CA

By research site
Valkyrie Clinical Trials· Los Angeles, CAChristiana Care Health Services, Christiana Hospital· Newark, DEBRCR Global· Plantation, FL

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