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

Head and Neck Neoplasms Clinical Trial

Official title:

Phase II Study of Durvalumab +/- Tremelimumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06446570
• Other study ID #: ESR-16-12012
• Status: Completed
• Phase: Phase 2
• Start date: September 10, 2017
• Est. completion date: June 3, 2021

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma

Description:

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 3, 2021
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• HNSCC

Intervention

Drug:
• Durvalumab,Tremelimumab
Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (RR)	RECIST1.1	24months
Secondary	•Progression-Free Survival (PFS)	Disease progression is assessed by RECIST 1.1.	24months
Secondary	•Overall Survival (OS)	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	24months
Secondary	•Toxicity	number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03	24months
Secondary	•biomarker	NGS, nanostring technology	24months