Chemoradiotherapy vs Immunotherapy with Radiation for Oral Cancer

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards

Eligibility Criteria

This trial is for adults with intermediate-risk HPV-positive oropharyngeal squamous cell carcinoma that hasn't spread. They must be in good physical condition, not have had certain previous cancer treatments, and agree to use effective contraception. People with a history of severe allergies to study drugs, other cancers (except some exceptions), autoimmune diseases, uncontrolled illnesses, or who are pregnant can't join.

Inclusion Criteria

I can care for myself and weigh more than 30 kg.

The following radiological investigations must be done within 8 weeks of randomization: CT or MRI of the neck (with PET-CT and head imaging as indicated); CT chest or x-ray, other radiology tests as clinically indicated

I can start treatment within a week of being chosen for the trial.

+14 more

Exclusion Criteria

My heart's electrical activity (QTcF) is normal and I don't have a family history of long QT syndrome.

I have never had a severe immune reaction from treatments or been on strong immune-suppressing drugs recently.

I haven't taken strong immune-weakening meds in the last 28 days, except for small doses of steroids or specific treatments.

+10 more

Participant Groups

The study compares the effectiveness of cisplatin plus radiotherapy against durvalumab (an immunotherapy drug) plus radiotherapy followed by either more durvalumab or a combination of tremelimumab (another immunotherapy drug) and durvalumab in preventing cancer recurrence.

3Treatment groups

Experimental Treatment

Active Control

Group I: Radiation/Durvalumab + Adjuvant Durvalumab/TremelimumabExperimental Treatment3 Interventions

ARM CLOSED TO ACCRUAL WITH AMENDMENT #1

Group II: Radiation/Durvalumab + Adjuvant DurvalumabExperimental Treatment2 Interventions

All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Concurrent Phase: Durvalumab IV 1500 mg, days -7 and 22 (the second dose is given concurrently with RT). Adjuvant Phase (to start 4 weeks after completion of concurrent phase): Durvalumab IV 1500 mg q4 weekly for 6 doses.

Group III: Radiation/CisplatinActive Control2 Interventions

All patients will receive standard fractionation radiation therapy (RT) scheme: 70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction) Cisplatin IV 100 mg/m2 days 1, 22, 43 concurrently with RT

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: