A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Takeda
Study ID
NCT04381650
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

  • TAK-981 — DRUG
    TAK-981 IV infusion.
  • Pembrolizumab — DRUG
    Pembrolizumab IV infusion.

Study Details

TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.

Key Dates

Start date
Aug 17, 2020
Status verified
Nov 2025
Primary completion
Oct 29, 2024
Completion
Oct 29, 2024

Study Design

Enrollment
161 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: TAK-981 40 mg + Pembrolizumab
    Participants received TAK-981 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the recommended Phase 2 dose (RP2D) was determined (for a maximum of 24 months).
  • Experimental: Dose Escalation: TAK-981 60 mg + Pembrolizumab
    Participants received TAK-981 60 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).
  • Experimental: Dose Escalation: TAK-981 90 mg + Pembrolizumab
    Participants received TAK-981 90 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).
  • Experimental: Dose Escalation: TAK-981 120 mg + Pembrolizumab
    Participants received TAK-981 120 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).
  • Experimental: Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg
    Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg
    Participants with NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion Phase: Cohort B: Cervical Cancer
    Participants with cervical cancer received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion Phase: Cohort C: MSS-CRC
    Participants with microsatellite stable colorectal cancer (MSS-CRC) received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion Phase: Cohort D: Cutaneous Melanoma
    Participants with cutaneous melanoma received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion Phase: Cohort E: Squamous NSCLC
    Participants with squamous NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
  • Experimental: Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC
    Participants with checkpoint inhibitors (CPI) refractory squamous or non-squamous NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Primary Outcome Measure

Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 24 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
University of California Irvine Medical CenterOrangeCalifornia92868-
Stanford Cancer Institute (SCI)StanfordCalifornia94305-
Yale Cancer CenterNew HavenConnecticut06520-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
The Center for Cancer and Blood Disorders - PPDSBethesdaMaryland20817-
Morristown Medical CenterMorristownNew Jersey07960-
Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Montefiore Einstein Cancer Center - BRANY - PPDSThe BronxNew York10461-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma73104-
Providence Cancer Institute, Franz ClinicPortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
UPMC Hillman Cancer CenterPittsburghPennsylvania15213-
University of Texas Southwestern Medical CenterDallasTexas75390-
START South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Virginia Cancer Specialists (Fairfax) - USORFairfaxVirginia22031-

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By research site
HonorHealth· Scottsdale, AZUniversity of California Irvine Medical Center· Orange, CAStanford Cancer Institute (SCI)· Stanford, CAYale Cancer Center· New Haven, CTGeorgia Cancer Center at Augusta University· Augusta, GAThe Center for Cancer and Blood Disorders - PPDS· Bethesda, MD

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