NCT06446570
Completed
Phase 2
Phase II Study of Durvalumab +/- Tremelimumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Seoul National University Hospital1 site in 1 country18 target enrollmentStarted: September 10, 2017Last updated:
InterventionsDurvalumab,Tremelimumab
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Response rate (RR)
Overview
Brief Summary
Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
Detailed Description
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent or metastatic HNSCC, regardless of PD-L1 or HPV status
- •ECOG PS 0-1
- •Ineligibility for local therapy (surgery or radiotherapy)
- •Prior palliative chemotherapy including platinum-based chemotherapy. When recurred within 6 months of definitive/neoadjuvant/adjuvant chemo- or chemoradiation, the chemotherapy is considered a line of therapy
- •At least one measurable lesion by RECIST ver 1.1
- •Adequate organ function for treatment
- •Absolute neutrophil count (ANC) ≥1000 cells/mm3
- •Hemoglobin: ≥ 9.0 g/dL
- •Platelets ≥100,000 cells/mm3
- •Estimated creatinine clearance ≥40 mL/min, or serum creatinine \<1.5 x institution upper limit of normal
Exclusion Criteria
- •Previous treatment with PD-1 or PDL-1 inhibitors
- •Nasopharyngeal carcinoma
- •Cytotoxic chemotherapy within 3 weeks of study entry; immunotherapy or investigational drug within 5 half-lives of study entry
- •Any major operation or irradiation within 4 weeks of baseline disease assessment. Palliative radiation is allowed
- •Symptomatic brain metastasis
- •Patients with known interstitial lung disease
- •Patients with uncontrolled or significant cardiovascular disease
- •Previous or concurrent malignancy (except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, thyroid cancer treated curatively) without evidence of recurrence for at least 3 years prior to study entry.
- •Pregnant or breast-feeding women
- •Systemic immunosuppressive therapy
Arms & Interventions
Durvalumab, tremelimumab
Experimental
Durvalumab is a human immunoglobulin (Ig) G1 kappa (IgG1κ) monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 on T-cells and CD80 on immune cells and is engineered to reduce antibody-dependent cell-mediated cytotoxicity.(IV class)
Tremelimumab is specific for human CTLA-4; cluster of differentiation a cell surface receptor that is expressed primarily on activated T cells and acts to inhibit their activation.(IV class)
Intervention: Durvalumab,Tremelimumab (Drug)
Outcomes
Primary Outcomes
Response rate (RR)
Time Frame: 24months
RECIST1.1
Secondary Outcomes
- •Progression-Free Survival (PFS)(24months)
- •Overall Survival (OS)(24months)
- •biomarker(24months)
- •Toxicity(24months)
Investigators
Study Sites (1)
Loading locations...
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