A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Part of paid clinical trials in Duarte, California.

Sponsor
Takeda
Study ID
NCT04879849
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Neoplasms

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    IV infusion.
  • TAK-676 — DRUG
    IV infusion.
  • Image-guided radiation therapy — RADIATION
    Radiation therapy.

Study Details

In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it. Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.

Key Dates

Start date
Sep 9, 2021
Status verified
Sep 2025
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676
    Participants will receive image-guided radiation therapy between Day -8 and Day -2. Participants will then receive pembrolizumab 200 milligram (mg), infusion, intravenously (IV), once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by TAK-676 infusion with escalating doses (0.2 mg and above), IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurs first.

Primary Outcome Measure

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity [ Time Frame: From first dose of study drug administration up to 32 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterDuarteCalifornia91010-3012-
University of ChicagoChicagoIllinois60637-1443-
Laura And Isaac Perlmutter Cancer CenterNew YorkNew York10016-4744-
Providence Portland Medical CenterPortlandOregon97213-2933-
Vanderbilt University Medical CenterNashvilleTennessee37232-0021-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
Cedars Sinai Medical Center· Duarte, CAUniversity of Chicago· Chicago, ILLaura And Isaac Perlmutter Cancer Center· New York, NYProvidence Portland Medical Center· Portland, ORVanderbilt University Medical Center· Nashville, TN

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