TAK-676-1003

Completed

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

Clinicaltrials.gov

WHO

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.

Interventional Phase 1 clinical trial.

What medical conditions were being studied?

Solid Tumors

What was the clinical trial testing?

Pembrolizumab, TAK-676, Image-guided radiation therapy

How many participants were enrolled?

Were placebos part of the clinical trial?

When was the clinical trial conducted?

Sep 2021 - Apr 2024

How long was participation in the clinical trial?

There will be many clinic visits. The number of visits will depend on the number of cycles of treatment. Participants will visit the clinic for a final check-up within 30 days after their treatment ended. They might continue to have check-ups every 12 weeks if they left the study for a reason apart from their cancer getting worse.

Sexes

All

Age

18+ Years

Healthy volunteers?

Both men and women can take part.

Must be 18 years or older.

Must have advanced non-small-cell lung cancer, triple-negative breast cancer, or squamous-cell carcinoma of the head and neck.

Must have previously had treatment with a checkpoint inhibitor.

Cannot have had a serious heart condition in the last 6 months

Cannot have a history of brain tumors unless treatment finished 4 or more weeks ago and participant is not taking steroids.

Cannot have a condition where the immune system attacks its own cells and tissues (autoimmune disease) or have an HIV infection.

Cannot have hepatitis.

Cannot have steroids or any anti-cancer treatment with capsules, tablets, or infusions in the last 14 days.

Cannot have previously had radiotherapy within 4 weeks of beginning study medication.

Cannot be a smoker.

Cannot have vaped in the last 90 days.

Cannot have low blood pressure that requires further testing or treatment.

Cannot have received a live vaccine within 28 days.

Cannot have had a stem cell or organ transplant.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

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 30 months]

Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: Up to 30 months]

Number of Participants Reporting One or More Treatment Emergent Serious Adverse events (TESAEs) [Time Frame: From first dose of study drug administration up to 30 months]

Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation [Time Frame: From first dose of study drug administration up to 30 months]

Secondary outcome measures

Overall Response Rate (ORR) Assessed by Investigator as per RECIST v1.1 [Time Frame: Up to 30 months]

Duration of Response (DOR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1 [Time Frame: From date of first documentation of cPR or better to the date of first documentation of progressive disease (PD) (up to 30 months)]

Time to Response (TTR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1 [Time Frame: From the date of first dose administration to the date of first documented cPR or better (Up to 30 months)]

Overall Response Rate Assessed by Investigator as per Modified Intratumoral Immunotherapy RECIST (modified itRECIST) [Time Frame: Up to 30 months]

Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated) [Time Frame: Up to 30 months]

Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated) [Time Frame: Up to 30 months]

Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated) [Time Frame: From date of first documentation of cPRirradiated or better to the date of first documentation of irradiated PD (up to 30 months)]

Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated) [Time Frame: From date of first documentation of cPRnonirradiated or better to the date of first documentation of nonirradiated PD (up to 30 months)]

Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated) [Time Frame: From the date of first dose administration to the date of first documented cPRirradiated or better (up to 30 months)]

Time to Response (TTR) For Tumors Outside the Radiation Field (TTRnonirradiated) [Time Frame: From the date of first dose administration to the date of first documented cPRnonirradiated or better (up to 30 months)]

Number of Participants with Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry [Time Frame: Up to approximately 30 months]

Recruitment Complete

Solid Neoplasms

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

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

About this clinical trial

At a glance