Clinical trial · Interventional
Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
Phase II Study of Durvalumab +/- Tremelimumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
NCT06446570CI-TRIAL-00077763completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab,Tremelimumab | Drug | Durvalumab/Tremelimumab Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab, tremelimumab
- description
- 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)
- interventionNames
- Drug: Durvalumab,Tremelimumab
Primary outcomes (1)
- measure
- Response rate (RR)
- timeFrame
- 24months
- description
- RECIST1.1
Secondary outcomes (4)
- measure
- •Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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. 9\. 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 14\. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation
References
Publications (0)
Data not yet available
No reference posted for this study.