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TAK-676 for Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Medical Center, Chicago, ILSquamous Cell Carcinoma+8 MoreTAK-676 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Squamous Cell Carcinoma of the Head and Neck
  • Non-Small Cell Lung Cancer
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
NEO-201 in combination with pembrolizumab
1
APG-157
1
BA3021

Study Objectives

4 Primary · 20 Secondary · Reporting Duration: Up to 30 months

Month 30
Duration of Response (DOR)
Duration of Response (DOR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
Month 30
Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated)
Irradiated Duration of Response (DORirradiated)
Month 30
Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated)
Nonirradiated Duration of Response (DORnonirradiated)
Month 30
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
Month 30
Time to Response (TTR)
Time to Response (TTR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
Month 30
Irradiated Time to Response (TTRirradiated)
Month 30
Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated)
Month 30
Nonirradiated Time to Response (TTRnonirradiated)
Time to Response (TTR) For Tumors Outside the Radiation Field (TTRnonirradiated)
Up to 30 months
Irradiated Overall Response Rate (ORRirradiated)
Nonirradiated Overall Response Rate (ORRnonirradiated)
Number of Participants with Dose-limiting Toxicities (DLTs)
Overall Response Rate (ORR)
Overall Response Rate (ORR) Assessed by Investigator as per RECIST v1.1
Overall Response Rate Assessed by Investigator as per Modified Intratumoral Immunotherapy RECIST (modified itRECIST)
Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated)
Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated)
Month 30
Number of Participants with Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
NEO-201 in combination with pembrolizumab
2
APG-157
2
BA3021

Trial Design

1 Treatment Group

Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676
1 of 1

Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: TAK-676 · No Placebo Group · Phase 1

Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676Experimental Group · 3 Interventions: Pembrolizumab, TAK-676, Image-guided radiation therapy · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 months

Who is running the clinical trial?

TakedaLead Sponsor
1,135 Previous Clinical Trials
4,063,431 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,089 Previous Clinical Trials
483,479 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced or metastatic NSCLC, TNBC, or SCCHN and have already tried and failed all standard treatments available to you. You must have adequate bone marrow, liver, and kidney function, and your heart must be functioning normally. Any side effects from previous treatments must have improved to a mild level, with the exception of hair loss, mild nerve damage, or stable hormonal imbalances that require treatment. Additionally, you must have previously received and not responded to CPIs.
References

Frequently Asked Questions

Are there still openings for potential study participants?

"Affirmative. Clinicaltrials.gov's details demonstrate that this study, which was initially posted on September 9th 2021, is still open to new participants. 65 individuals are anticipated at seven different clinical sites." - Anonymous Online Contributor

Unverified Answer

Are there any previous experiments conducted involving TAK-676?

"Presently, there are 961 experiments ongoing that utilize TAK-676 with 122 Phase 3 trials. Houston, TX hosts a number of these tests; however, the total count for locations running TAK-676 studies is 35731." - Anonymous Online Contributor

Unverified Answer

What potential risks have been observed with TAK-676 administration?

"There is scarce data confirming the efficacy and safety of TAK-676, thus it was assigned a score of 1." - Anonymous Online Contributor

Unverified Answer

Are there any Canadian healthcare facilities participating in this research?

"Patients can access this clinical trial at the Providence Portland Medical Center (Portland, Oregon), Cedars Sinai Medical Centre (Pittsburgh, Pennsylvania) and Laura And Isaac Perlmutter Cancer Center (West Hollywood, California). There are 7 other accessible sites." - Anonymous Online Contributor

Unverified Answer

What is the ultimate goal of this clinical investigation?

"Takeda Pharmaceuticals, the trial sponsor, has outlined a range of primary and secondary outcomes. The primary outcome is Dose-limiting Toxicities (DLT), which will be monitored over a 30 month period from initial drug administration. Additionally, Nonirradiated Overall Response Rate (ORRnonirradiated), Irradiated Overall Response Rate (ORRirradiated) and Standard Overall Response Rate (ORR) are being assessed using RECIST V1.1 criteria as predetermined by the investigator." - Anonymous Online Contributor

Unverified Answer

What pathologies is TAK-676 typically employed to address?

"TAK-676 can be employed to treat malignant neoplasms, inoperable melanoma, and cases of high microsatellite instability." - Anonymous Online Contributor

Unverified Answer

Approximately how many participants have been included in this research endeavor?

"Takeda, the sponsor of this trial, requires 65 patients to meet their inclusion criteria in order for it to begin. The study will be taking place at Providence Portland Medical Center (Oregon) and Cedars Sinai Medical Centre (Pennsylvania)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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