Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

Conditions

• Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• AZD9150 — DRUG
  AZD9150
• MEDI4736 — DRUG
  MEDI4736
• AZD5069 — DRUG
  AZD5069
• tremelimumab (treme) — DRUG
  tremelimumab

Study Details

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

Key Dates

Start date

Aug 6, 2015

Status verified

Jan 2026

Primary completion

Feb 28, 2020

Completion

Oct 8, 2025

Study Design

Enrollment

340 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A1: AZD9150 / MEDI4736
  Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.
• Experimental: Part A2: AZD5069 / MEDI4736
  Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.
• Experimental: Part B1:AZD9150+MEDI4736:PDL1 pretreated
  Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
• Experimental: Part B2:AZD5069+MEDI4736:PDL1 pretreated
  Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
• Experimental: Part B3: AZD9150+MED4736:naiive 2L
  Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
• Experimental: Part B4:AZD5069+MEDI4736:naiive patients
  Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.
• Experimental: Part B5: AZD9150 in naiive patients
  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
• Experimental: Part B6:AZD5069 in naiive patients
  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
• Experimental: Part A3: AZD5069/MEDI4736
  Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies
• Experimental: Part A4: AZD9150/Treme/MEDI4736
  Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
• Experimental: Part A5: AZD5069/Treme/MEDI4736
  Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.
• Experimental: Part A6: AZD9150/MEDI4736
  Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
• Experimental: Part A7: AZD5069/MEDI4736
  Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.
• Experimental: Part B7: AZD9150+MEDI4736: naiive 1L
  Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival
• Experimental: Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
  Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

Primary Outcome Measure

Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion [ Time Frame: 35 days ]

Locations (19)

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