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Checkpoint Inhibitor

TAK-981 + Pembrolizumab for Solid Cancers

Q: What medical condition is TAK-981 most effective in alleviating?

<p>TAK-981 is a medication used to treat <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. It can also help patients with microsatellite instability high and disease progression after chemotherapy, as well as those who have unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My cancer is advanced and cannot be removed by surgery.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)

+4 more

Secondary outcome measures

Phase 1: AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981

Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981

Phase 1: CL: Total Clearance After Intravenous Administration for TAK-981

+17 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 2

~2010

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,206 Previous Clinical Trials

4,188,020 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

56 Previous Clinical Trials

11,985 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,215 Previous Clinical Trials

499,565 Total Patients Enrolled

Media Library

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

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

Solid Tumors Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04381650 — Phase 1 & 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04381650 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical condition is TAK-981 most effective in alleviating?

"TAK-981 is a medication used to treat cancer. It can also help patients with microsatellite instability high and disease progression after chemotherapy, as well as those who have unresectable melanoma."

Answered by AI

Are people needed for this research project?

"That is correct. The information available on clinicaltrials.gov does show that this particular trial is still looking for volunteers. This specific trial was first announced on 8/17/2020 and the most recent update was 9/13/2022. So far, 11 different locations have been used to recruit the 265 participants needed for the study."

Answered by AI

What is the extent of research on TAK-981?

"TAK-981 is currently being researched in 1003 clinical trials, 122 of which are in the final stage. Most of these studies taking place in Houston, Texas; however, there are 36125 research sites for this medication globally."

Answered by AI

How many different places are conducting this trial?

"There are 11 sites available for this clinical trial, which include the Providence Cancer Institute, Franz Clinic in Portland, Honor Health Research Institute in Scottsdale, and Henry Ford Hospital in Detroit."

Answered by AI

What is the maximum sample size for this research project?

"That is accurate. The clinical trial was originally posted on 8/17/2020, as the website clinicaltrials.gov attests, and is currently seeking patients. 11 different hospitals or medical facilities are participating in this study which will enroll 265 individuals in total."

Answered by AI

Recent research and studies

BloodJournal

The Sumoylation Inhibitor Subasumstat Potentiates Rituximab Activity by Ifn1-dependent Macrophage and NK Cell Stimulation

Nakamura, Akito, Stephen Grossman, Keli Song, Kristina Xega, Yuhong Zhang, Donna Cvet, Allison Berger, Gary Shapiro, and Dennis Huszar. 2022. “The Sumoylation Inhibitor Subasumstat Potentiates Rituximab Activity by Ifn1-dependent Macrophage and NK Cell Stimulation”. Blood. American Society of Hematology. doi:10.1182/blood.2021014267.

clinicaltrials.govStudy

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

2020. "A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04381650.