Durvalumab +/− Tremelimumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find the highest dose of durvalumab or of durvalumab with tremelimumab that can be tolerated without causing very severe side effects when receiving standard chemotherapy and to see what effects the study drugs has on this type of cancer. Patients may receive durvalumab alone or in combination with tremelimumab.

Eligibility Criteria

This trial is for adults with advanced solid tumors that can't be cured by surgery or other therapies. They must have recovered from previous treatments, not had severe reactions to similar drugs, and agree to use effective contraception. People with certain autoimmune diseases, untreated heart conditions, or who are pregnant can't join.

Inclusion Criteria

I am eligible and can receive the treatment options listed in the study.

My cancer is advanced, cannot be surgically removed, and cannot be cured.

I have small cell lung cancer that hasn't been treated yet.

Exclusion Criteria

I am currently receiving treatment for another cancer.

I have had autoimmune or inflammatory disorders in the last 3 years.

I am allergic to durvalumab, tremelimumab, or their ingredients.

Participant Groups

The study tests the highest tolerable doses of durvalumab alone or combined with tremelimumab alongside standard chemotherapy in patients with incurable solid malignancies. It aims to determine safety and effects on cancer at these doses.

Group I: durvalumab ± tremelimumab Experimental Treatment 2 Interventions

durvalumab; Day 1 every 3 weeks or 4 weeks tremelimumab; every 3-6 weeks for a total of 1-6 doses

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

🇪🇺 Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

🇺🇸 Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

🇯🇵 Approved in Japan as Imfinzi for:

• Not specified in provided sources

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ottawa Hospital Research Institute Ottawa, Canada

University Health Network Toronto, Canada

CHUM - Hopital Notre-Dame Montreal, Canada

BCCA - Vancouver Cancer Centre Vancouver, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group Lead Sponsor

AstraZeneca Industry Sponsor

References