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Antisense Oligonucleotides

MEDI4736 + AZD9150/AZD5069 for Head & Neck Cancer

Phase 1 & 2
Waitlist Available
Led By Dr David Hong, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1
Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies
Must not have
Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years
Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 3.3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study the safety and effectiveness of a new drug in people with a certain medical condition. It is split into two parts, with the first part focusing on safety and the second part focusing on effectiveness.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include immune system reactions that may cause inflammation in various organs, infusion-related reactions, fatigue, digestive issues like diarrhea or colitis, blood disorders such as anemia or clotting problems, increased risk of infections due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had 1 to 3 rounds of chemotherapy to reduce my tumor size.
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I have had 3 or fewer previous cancer treatments.
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My cancer does not respond to standard treatments or no treatment exists.
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My prostate cancer is resistant to hormonal therapy.
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My head or neck cancer cannot be cured with surgery or radiation.
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My cancer can be measured and fits certain size criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer type besides SCCHN or was treated for another invasive cancer in the last 3 years.
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I have had severe side effects from previous immunotherapy.
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I have had an organ transplant and am on immunosuppressive drugs.
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I haven't had a live vaccine in the last 30 days and can take pills.
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I do not have active brain cancer or previous treatments with certain antibodies.
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I do not have brain metastases.
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I have not been treated with certain antibodies before.
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I have or had inflammatory bowel disease or a primary immune deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 3.3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 3.3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion
Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion
Part A: Safety and Tolerability in Terms of Adverse Events
+1 more
Secondary study objectives
Part A and B: AZD5069 AUC0-12h at Lead in Day -7
Part A and B: AZD5069 AUCss at Cycle 2 Day 1
Part A and B: AZD5069 Cmax at Lead in Day -7
+18 more

Side effects data

From 2015 Phase 1 trial • 58 Patients • NCT01839604
67%
Platelet count decreased
60%
Aspartate aminotransferase increased
60%
Alanine aminotransferase increased
27%
Decreased apetite
27%
Dyspepsia
27%
Neutrophil count decreased
20%
Fatigue
20%
Productive cough
20%
Anaemia
20%
Neutropenia
13%
Thrombocytopenia
13%
Blood bilirubin increased
13%
Haemoptysis
13%
Cough
13%
Rhinorrhoea
13%
Hepatic function abnormal
13%
Abdominal pain
13%
Constipation
13%
Headache
13%
Hypertension
7%
Pruritus
7%
Rash
7%
White blod cell count decreased
7%
Malaise
7%
Upper respiratory tract infection
7%
Abdominal pain upper
7%
Prothrombin time prolonged
7%
Cellulitis
7%
Diarrhoea
7%
Abdominal distension
7%
Pyrexia
7%
Haematuria
7%
Oropharyngeal pain
7%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
3 mg/kg
1.5 mg/kg
2.5 mg/kg
2 mg/kg
AZD9150 1mg/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups
Experimental Treatment
Group I: Part B8: AZD9150 (every other week)+MEDI4736: naive 1LExperimental Treatment2 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 1LExperimental Treatment2 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 patientsExperimental Treatment1 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 patientsExperimental Treatment1 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 patientsExperimental Treatment2 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 2LExperimental Treatment2 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 pretreatedExperimental Treatment2 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 pretreatedExperimental Treatment2 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/MEDI4736Experimental Treatment2 Interventions
Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.
Group X: Part A6: AZD9150/MEDI4736Experimental Treatment2 Interventions
Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
Group XI: Part A5: AZD5069/Treme/MEDI4736Experimental Treatment3 Interventions
Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.
Group XII: Part A4: AZD9150/Treme/MEDI4736Experimental Treatment3 Interventions
Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
Group XIII: Part A3: AZD5069/MEDI4736Experimental Treatment2 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 / MEDI4736Experimental Treatment2 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 / MEDI4736Experimental Treatment2 Interventions
Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9150
2018
Completed Phase 1
~200
MEDI4736
2016
Completed Phase 3
~5560
AZD5069
2010
Completed Phase 2
~1640

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,271 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
788,417 Total Patients Enrolled
Dr David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

AZD5069 (Antisense Oligonucleotides) Clinical Trial Eligibility Overview. Trial Name: NCT02499328 — Phase 1 & 2
Squamous Cell Carcinoma Research Study Groups: Part B5: AZD9150 in naiive patients, Part A7: AZD5069/MEDI4736, Part A4: AZD9150/Treme/MEDI4736, Part B2:AZD5069+MEDI4736:PDL1 pretreated, Part B7: AZD9150+MEDI4736: naiive 1L, Part B4:AZD5069+MEDI4736:naiive patients, Part A6: AZD9150/MEDI4736, Part A3: AZD5069/MEDI4736, Part A2: AZD5069 / MEDI4736, Part B6:AZD5069 in naiive patients, Part A5: AZD5069/Treme/MEDI4736, Part B8: AZD9150 (every other week)+MEDI4736: naive 1L, Part B1:AZD9150+MEDI4736:PDL1 pretreated, Part B3: AZD9150+MED4736:naiive 2L, Part A1: AZD9150 / MEDI4736
Squamous Cell Carcinoma Clinical Trial 2023: AZD5069 Highlights & Side Effects. Trial Name: NCT02499328 — Phase 1 & 2
AZD5069 (Antisense Oligonucleotides) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02499328 — Phase 1 & 2
~33 spots leftby Dec 2025
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