MEDI4736 + AZD9150/AZD5069 for Head & Neck Cancer

Recruiting in Palo Alto (17 mi)

+45 other locations

Overseen by David Hong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Trial Summary

What is the purpose of this trial?

This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation, safety run-in Part A and a dose-expansion Part B

Research Team

David Hong, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with advanced solid tumors or relapsed metastatic squamous cell carcinoma of the head and neck, who have tried ≤3 previous cancer treatments (or none for certain arms), can join. They must be in good physical condition (ECOG PS 0 or 1) with proper organ function and measurable disease. Women of childbearing age and men with partners of childbearing potential must use effective birth control.

Inclusion Criteria

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

I have had 1 to 3 rounds of chemotherapy to reduce my tumor size.

I have had 3 or fewer previous cancer treatments.

Exclusion Criteria

I have spinal cord compression but haven't needed steroids for it in the last 4 weeks.

I have another cancer type besides SCCHN or was treated for another invasive cancer in the last 3 years.

I have had severe side effects from previous immunotherapy.

Treatment Details

Interventions

• AZD5069 (Antisense Oligonucleotides)
• AZD9150 (Antisense Oligonucleotides)
• MEDI4736 (Monoclonal Antibodies)

Trial Overview The trial is testing MEDI4736 combined with either AZD9150 or AZD5069, plus tremelimumab in some cases, to treat advanced cancers. It's a two-part study: Part A finds safe doses; Part B expands on those doses to further assess safety and effectiveness.

Participant Groups

Group I: Part B8: AZD9150 (every other week)+MEDI4736: naive 1L Experimental Treatment 2 Interventions

Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

Group II: Part B7: AZD9150+MEDI4736: naiive 1L Experimental Treatment 2 Interventions

Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

Group III: Part B6:AZD5069 in naiive patients Experimental Treatment 1 Intervention

Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

Group IV: Part B5: AZD9150 in naiive patients Experimental Treatment 1 Intervention

Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

Group V: Part B4:AZD5069+MEDI4736:naiive patients Experimental Treatment 2 Interventions

Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VI: Part B3: AZD9150+MED4736:naiive 2L Experimental Treatment 2 Interventions

Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VII: Part B2:AZD5069+MEDI4736:PDL1 pretreated Experimental Treatment 2 Interventions

Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group VIII: Part B1:AZD9150+MEDI4736:PDL1 pretreated Experimental Treatment 2 Interventions

Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

Group IX: Part A7: AZD5069/MEDI4736 Experimental Treatment 2 Interventions

Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.

Group X: Part A6: AZD9150/MEDI4736 Experimental Treatment 2 Interventions

Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.

Group XI: Part A5: AZD5069/Treme/MEDI4736 Experimental Treatment 3 Interventions

Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.

Group XII: Part A4: AZD9150/Treme/MEDI4736 Experimental Treatment 3 Interventions

Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

Group XIII: Part A3: AZD5069/MEDI4736 Experimental Treatment 2 Interventions

Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies

Group XIV: Part A2: AZD5069 / MEDI4736 Experimental Treatment 2 Interventions

Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Group XV: Part A1: AZD9150 / MEDI4736 Experimental Treatment 2 Interventions

Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

MedImmune LLC

Industry Sponsor

Trials

348

Recruited

788,000+

Founded

1988

Headquarters

Gaithersburg, USA

Known For

Biologics research

Top Products

Synagis, FluMist

Dr. Reginald Seeto

MedImmune LLC

Chief Medical Officer since 2008

MD from University of Sydney, B.Sc. from University of Sydney

Peter Greenleaf

MedImmune LLC

Chief Executive Officer since 2006

MBA from St. Joseph’s University, B.S. from Western Connecticut State University