Xevinapant + Radiotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+272 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: EMD Serono Research & Development Institute, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Xevinapant combined with radiotherapy for high-risk head and neck cancer patients who can't use standard treatment. The drug aims to make cancer cells more sensitive to radiation, improving treatment effectiveness. Xevinapant is a newer drug being tested to enhance the sensitivity of cancer cells to radiation in high-risk head and neck cancer patients.

Research Team

Medical Responsible

Principal Investigator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility Criteria

This trial is for adults with high-risk, resected head and neck cancer who can't receive cisplatin. They must have had surgery recently, no remaining disease visible on scans, and a risk of relapse. Participants need to be able to handle standard radiotherapy and have good organ function.

Inclusion Criteria

Other protocol-defined inclusion criteria could apply

I can handle standard cancer radiation therapy and am mostly active.

I cannot receive high-dose cisplatin due to kidney issues, hearing loss, nerve damage, or frailty.

See 4 more

Exclusion Criteria

Other protocol-defined exclusion criteria could apply

Any condition, other than SCCHN, deemed inappropriate risk or contraindication by the Investigator

My surgery did not remove all of the cancer.

See 4 more

Treatment Details

Interventions

IMRT (Radiation)
Xevinapant (Debio 1143) (Apoptosis Inducer)

Trial OverviewThe study tests if Xevinapant (Debio 1143) improves outcomes when added to radiotherapy compared to placebo in patients ineligible for cisplatin chemotherapy. It's an 18-week treatment followed by regular check-ups for up to five years.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: Xevinapant (Debio 1143) + IMRTExperimental Treatment2 Interventions

Group II: Arm B: Placebo + IMRTPlacebo Group2 Interventions

IMRT is already approved in Canada, Japan for the following indications: