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TAK-676 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Participants must have at least 2 measurable lesions with at least one inside and at least one other outside of the radiation field, accessible for biopsy, and consent to tumor biopsy at screening and during treatment
Must not have
Chronic, active hepatitis
Receipt of live attenuated vaccine within 28 days of study drug(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Summary

This trial is testing a combination of two immunotherapy drugs, TAK-676 and pembrolizumab, to see if they can improve outcomes for people with non-small cell lung cancer, triple-negative breast cancer, and squamous cell carcinoma of the head and neck.

Who is the study for?
Adults with advanced or metastatic non-small-cell lung cancer, triple-negative breast cancer, or squamous-cell carcinoma of the head and neck who have measurable lesions for biopsy. Participants must be in good physical condition (ECOG 0-1), have recovered from previous therapies to a certain extent, and have proper heart function. Smokers, those with recent serious health issues, uncontrolled autoimmune diseases, HIV infection or chronic hepatitis are excluded.Check my eligibility
What is being tested?
The trial is testing TAK-676 combined with pembrolizumab following radiotherapy on patients with specific cancers. The goal is to determine improvement in condition, side effects experienced and the maximum tolerable dose of TAK-676 when administered after radiation therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion treatments such as fatigue, allergic responses; organ inflammation; immune system complications that could lead to infections; and possibly other symptoms not yet known due to the investigational nature of TAK-676.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have at least 2 tumors that can be measured, with one inside and one outside the radiation area, and I agree to biopsies.
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My cancer is advanced and I have a history of specific treatments with my organs working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have ongoing, active hepatitis.
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I have not received a live vaccine in the last 28 days.
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I have received a stem cell or organ transplant.
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I currently have a serious infection or a high fever due to cancer.
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I have experienced moderate to severe low blood pressure.
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I have been diagnosed with a specific lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Reporting One or More Treatment Emergent Serious Adverse events (TESAEs)
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation
+1 more
Secondary outcome measures
Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated)
Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated)
Duration of Response (DOR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
TAK-676
2021
Completed Phase 1
~50
Image-guided radiation therapy
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,213 Previous Clinical Trials
4,187,119 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,230 Previous Clinical Trials
501,056 Total Patients Enrolled

Media Library

Image-guided radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT04879849 — Phase 1
Oral Squamous Cell Carcinoma Research Study Groups: Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676
Oral Squamous Cell Carcinoma Clinical Trial 2023: Image-guided radiation therapy Highlights & Side Effects. Trial Name: NCT04879849 — Phase 1
Image-guided radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879849 — Phase 1
~9 spots leftby Jul 2025