Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma

Phase 2

Completed

• Conditions: HNSCC; Head and Neck Neoplasms
• Interventions: Drug: Durvalumab,Tremelimumab

• Registration Number: NCT06446570
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2017-09-10
• Primary Completion: 2019-02-22
• Study Completion: 2021-06-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Last Update Submitted: 2024-05-31
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 1. Recurrent or metastatic HNSCC, regardless of PD-L1 or HPV status 2. Age ≥20 3. ECOG PS 0-1 4. Ineligibility for local therapy (surgery or radiotherapy) 5. 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 6. At least one measurable lesion by RECIST ver 1.1 7. 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
• Bilirubin ≤1.5 x upper limit of normal (ULN)
• AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
• ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases) 8. 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention 9. The patient has provided signed informed consent

Exclusion Criteria

• 1. Previous treatment with PD-1 or PDL-1 inhibitors 2. Nasopharyngeal carcinoma 3. Cytotoxic chemotherapy within 3 weeks of study entry; immunotherapy or investigational drug within 5 half-lives of study entry 4. Any major operation or irradiation within 4 weeks of baseline disease assessment. Palliative radiation is allowed 5. Symptomatic brain metastasis 6. Patients with known interstitial lung disease 7. Patients with uncontrolled or significant cardiovascular disease 8. 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.

  2. Pregnant or breast-feeding women 10. Systemic immunosuppressive therapy 11. Active autoimmune disease 12. Patient who have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies) (inactive HBV carrier with adequate prophylactic antiviral agent can be enrolled) 13. Body weight <30kg

  3. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durvalumab, tremelimumab	Durvalumab,Tremelimumab	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)

Primary Outcome Measures

Name	Time	Method
Response rate (RR)	24months	RECIST1.1

Secondary Outcome Measures

Name	Time	Method
•Progression-Free Survival (PFS)	24months	Disease progression is assessed by RECIST 1.1.
•Overall Survival (OS)	24months	Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period
•biomarker	24months	NGS, nanostring technology
•Toxicity	24months	number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of