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Checkpoint Inhibitor

TAK-981 + Pembrolizumab for Solid Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a histologically or cytologically documented, advanced (metastatic and/or unresectable) cancer as specified in the protocol

Has a performance status of 0 or 1 on the Eastern Cooperative Group Oncology (ECOG) Performance Scale

Must not have

Major surgery ≤14 days from the first dose of study drug and not fully recovered

Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P-450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination treatment of TAK-981 with pembrolizumab to see if it is safe and effective in treating people with advanced or metastatic solid tumors.

Who is the study for?

This trial is for adults with certain advanced or metastatic solid tumors that have relapsed or not responded to standard treatments. Eligible cancers include non-squamous and squamous NSCLC, cervical cancer, colorectal cancer (MSS-CRC), and cutaneous melanoma. Participants must have measurable disease, be in good physical condition (ECOG 0-1), have a heart function above a set threshold (LVEF ≥40%), recovered from previous therapy side effects, and adequate organ function.

What is being tested?

The study tests TAK-981 combined with pembrolizumab on patients with specific solid tumors. The treatment involves cycles of 21 days each and can last up to two years unless there are reasons to stop earlier. Researchers want to see how safe this combo is, how well patients tolerate it, and if it effectively fights the cancer.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related responses during drug administration, fatigue, digestive issues like nausea or diarrhea, blood cell count changes which could increase infection risk or cause anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had major surgery less than 14 days ago and haven't fully recovered.

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I am taking or need to take strong medication that affects liver enzymes.

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I am currently being treated for an infection.

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I stopped an immune therapy due to side effects.

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I have had lung inflammation or lung disease that needed steroids.

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I have lung inflammation not caused by an infection.

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I have untreated or uncontrollable brain cancer spread.

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I take more than 10 mg/day of prednisone or similar drugs for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Number of Participants With Clinically Significant Laboratory Values

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs)

+2 more

Secondary study objectives

Phase 1: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose in Blood

Phase 1: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Blood

Phase 2: Overall Survival (OS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLCExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with checkpoint inhibitors (CPI) refractory squamous or nonsquamous NSCLC on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group II: Dose Expansion Phase: Cohort E: Squamous NSCLCExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with squamous non-small cell lung cancer (NSCLC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group III: Dose Expansion Phase: Cohort D: Cutaneous MelanomaExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with cutaneous melanoma on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group IV: Dose Expansion Phase: Cohort C: MSS-CRCExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with microsatellite stable colorectal cancer (MSS-CRC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group V: Dose Expansion Phase: Cohort B: Cervical CancerExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with cervical cancer on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group VI: Dose Expansion Phase: Cohort A: Non-squamous NSCLCExperimental Treatment2 Interventions

TAK-981 as IV infusion in participants with non-squamous non-small cell lung cancer (NSCLC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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.

Group VII: Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose)Experimental Treatment2 Interventions

Escalating doses of TAK-981 with starting dose of 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 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 RP2D is determined (for a maximum of 24 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-981

2020

Completed Early Phase 1

~20

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,235 Previous Clinical Trials

4,147,856 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

10,724 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,271 Previous Clinical Trials

503,876 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04381650 — Phase 1 & 2

$Solid Tumors Research Study Groups: Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC, Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose), Dose Expansion Phase: Cohort D: Cutaneous Melanoma, Dose Expansion Phase: Cohort E: Squamous NSCLC, Dose Expansion Phase: Cohort C: MSS-CRC, Dose Expansion Phase: Cohort A: Non-squamous NSCLC, Dose Expansion Phase: Cohort B: Cervical Cancer$