Phase 3
N=823
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT02551159 ↗Enrolled (actual)
823
Serious AEs
42.2%
Results posted
Oct 2021
Primary outcome: Primary: Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) — 162; 84; 77; 1 Participants — p=0.787
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MEDI4736 (Biological); Tremelimumab (Biological); MEDI4736+Tremelimumab (Biological); Cetuximab (Biological); 5-fluorouracil (5FU) (Drug); Cisplatin (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) |
162; 84; 77; 1; 1; 3 | 0.787 |
| PRIMARY Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup |
11.2; 10.9; 10.9 | — |
| SECONDARY Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC) |
162; 84; 77 | 0.634 |
| SECONDARY Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup |
49.3; 48.0; 44.0; 31.8; 34.7; 30.8 | — |
| SECONDARY Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup |
2.8; 2.8; 5.3 | 0.287 |
| SECONDARY Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup |
48; 16; 47; 142; 83; 47 | <0.001 sig |
| SECONDARY Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup |
6.5; 12.3; 4.2 | — |
| SECONDARY Overall Survival (OS) Status in the All-comers (Full Analysis Set) |
356; 176; 171; 4; 3; 6 | 0.811 |
| SECONDARY Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set) |
10.7; 9.9; 10.3 | — |
| SECONDARY Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set) |
46.5; 42.8; 43.8; 30.7; 31.2; 29.7 | — |
| SECONDARY Progression Free Survival (PFS) in the All-comers (Full Analysis Set) |
2.8; 2.8; 5.4 | 0.006 sig |
| SECONDARY Objective Response Rate (ORR) in the All-comers (Full Analysis Set) |
90; 35; 101; 323; 169; 105 | <0.001 sig |
| SECONDARY Duration of Response (DoR) in the All-comers (Full Analysis Set) |
9.2; 11.9; 4.2 | — |
Summary
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years at the time of screening
- Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
- A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
- No prior systemic chemotherapy for recurrent or metastatic disease
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- No prior exposure to immune-mediated therapy,
Exclusion Criteria
- Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
- Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
- Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis
Data sourced from ClinicalTrials.gov (NCT02551159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.