Durvalumab Plus Tremelimumab Combined With Proton Therapy for HNSCC
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ClinicalTrials.gov Identifier: NCT03450967 |
Recruitment Status : Unknown
Verified August 2021 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was: Active, not recruiting
First Posted : March 1, 2018
Last Update Posted : August 10, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | February 23, 2018 | ||||
First Posted Date ICMJE | March 1, 2018 | ||||
Last Update Posted Date | August 10, 2021 | ||||
Actual Study Start Date ICMJE | April 11, 2018 | ||||
Actual Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Response rate [ Time Frame: about 24months ] according to RECIST version 1.1
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Durvalumab Plus Tremelimumab Combined With Proton Therapy for HNSCC | ||||
Official Title ICMJE | A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab Combined With Proton Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | ||||
Brief Summary |
Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination until progression.). Proton therapy 5 GyE x 5 fractions - Study Assessments and Criteria for Evaluation: Safety Assessments: according to NCI CTCAE version 4.0 Efficacy Assessments: according to RECIST version 1.1 - Statistical Methods and Data Analysis: PFS: from the date of treatment to the date of progression or death or last follow-up OS: from the date of treatment to the date of death or last follow-up - Sample Size Determination: Patients must have a histologically confirmed diagnosis of HNSCC. In this phase II study, up to approximately 27 eligible patients will be enrolled. It is anticipated that full accrual to this study will take approximately 24 months. H0: Objective response rate ≤10% H1: Objective response rate ≥35% According to Simon's two-stage optimal design (power of 90% and one-sided alpha of 0.05), this study needs total 27 evaluable patients. At the first stage, 11 patients would be enrolled. If two or more among them achieve objective response, the study will go forward the second stage. At the second stage, 16 additional patients (total 27 patients) would be enrolled. Among the total 27 evaluable patients, six or more objective responses are necessary for this drug to be evaluated further in the group of R/M HNSCC |
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Detailed Description | The incidence of Head and neck cancer (HNC) is approximately 6% of all cases with a world annual incidence and nearly 90 to 95% of HNC is squamous cell carcinoma (HNSCC). [1] For patients with recurrent or metastatic HNSCC (R/M HNSCC), cytotoxic-based chemotherapy remains the standard therapeutic option. The median survival of these patients treated with cytotoxic-based chemotherapy, however, is only 6 to 10 months. For those who are not candidates for chemotherapy, the prognosis is even worse with median survival of 3 to 6 months. [2-4] Thus, new therapeutic options for these patients are needed to improve the treatment outcomes. We hypothesize that durvalumab plus tremelimumab combined with proton therapy would be effective in R/M HNSCC. The combination of immunotherapy and RT can be effective regimen because immunologic response might be enhanced by RT through the alteration of microenvironment within the irradiated field, tumor antigen release and "abscopal effect" at distant metastatic sites. In addition, the benefit of proton therapy is to deliver RT dose just to target lesion. The irradiated volume can be significantly reduced with proton therapy compared to X-ray treatment, thus proton therapy will provide better quality of life compared to X-ray during palliative RT. Patients in the durvalumab (MEDI4736) + tremelimumab combination therapy treatment group will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 4 doses/cycles each, followed by durvalumab (MEDI4736) 1500mg Q4W until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. The first durvalumab (MEDI4736) monotherapy dose at 1500mg Q4W will be 4 weeks after the final dose of durvalumab (MEDI4736) in combination with tremelimumab. Tremelimumab will be administered first; the durvalumab (MEDI4736) infusion will start approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion. If there are no clinically significant concerns after the first cycle, then, at the discretion of the Investigator, all other cycles of durvalumab (MEDI4736) can be given immediately after the tremelimumab infusion has finished. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Head and Neck Squamous Cell Carcinoma | ||||
Intervention ICMJE | Drug: Durvalumab Plus Tremelimumab
Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination until progression.).
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Study Arms ICMJE | Experimental: Durvalumab Plus Tremelimumab
Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination until progression.).
Intervention: Drug: Durvalumab Plus Tremelimumab
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE |
31 | ||||
Original Estimated Enrollment ICMJE |
27 | ||||
Estimated Study Completion Date ICMJE | March 2022 | ||||
Actual Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03450967 | ||||
Other Study ID Numbers ICMJE | 2017-09-026 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Myung-Ju Ahn, Samsung Medical Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Samsung Medical Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Samsung Medical Center | ||||
Verification Date | August 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |