Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin (CARSKIN)
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ClinicalTrials.gov Identifier: NCT02883556 |
Recruitment Status :
Completed
First Posted : August 30, 2016
Last Update Posted : January 13, 2021
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 25, 2016 | ||||||
First Posted Date ICMJE | August 30, 2016 | ||||||
Last Update Posted Date | January 13, 2021 | ||||||
Actual Study Start Date ICMJE | March 27, 2017 | ||||||
Actual Primary Completion Date | March 23, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Response rate (RR) [ Time Frame: 15 weeks ] Response rate (RR) at 15 weeks (RECIST v.1.1) in the whole sample by CT or MRI Response Evaluation Criteria in Solid Tumors with central radiology review
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin | ||||||
Official Title ICMJE | Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin | ||||||
Brief Summary | The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient with locally advanced or metastatic squamous cell carcinoma of the skin | ||||||
Detailed Description | Agents blocking the Programmed Cell Death 1(PD1)/Programmed Cell Death 1-Ligand 1 (PD-L1) pathway have demonstrated objective, durable tumor regressions in patients with advanced solid malignancies and efficacy has been linked to PD-L1 expression. PD-L1 expression by tumour cells is the strongest single predictor of response to anti-PD1 therapy (J Taube, R Anders et al, Clin Cancer Res 2014). Pembrolizumab (MK-3475) is a high-affinity humanized monoclonal anti-PD1 antibody. It leads to dual PD1-ligand blockade of PD-L1 and PD-L2 that may reactivate the immune surveillance and elicit anti-tumour response. It has antitumor activity in melanoma and NSCLC (phase III trials). Pembrolizumab might be of interest in unresectable squamous cell carcinomas of the skin (SCCS). Approximately 20% to 30% of non-melanoma skin cancers are SCCS. Most patients with primary SCCS have an excellent prognosis, but SCCS can progress to advanced stages that are impossible to treat by surgical excision or radiotherapy. Few therapeutic options are available for these tumors. Conventional chemotherapy, such as cisplatin-based combinations, has some efficacy, but the toxic effects of these combinations often prohibit their use in elderly patients. Epidermal Growth Factor (EGFR) signaling antagonists have activity only in a subset of patients. New therapeutic options are needed for patients with advanced SCCS. No trial evaluating pembrolizumab in human SCCS is ongoing. Investigators hypothesize that: i) PD-L1 is expressed in SCCS as in HNSCC ii) pembrolizumab may be effective as a single agent in patients with unresectable SCCS iii) Efficacy of pembrolizumab is correlated to PD-L1 expression in SCCS. Investigators therefore intend to determine the efficacy and safety of single agent pembrolizumab in all patients and in patients with PD-L1-positive unresectable SCCS naïve of chemotherapy and of EGFR inhibitors. |
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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 | Carcinoma, Squamous Cell | ||||||
Intervention ICMJE | Drug: Pembrolizumab
200 mg, administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops.
Other Name: MK-3475, KEYTRUDA
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Study Arms ICMJE | Experimental: Pembrolizumab 200 mg
Pembrolizumab 200 mg administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops.
Intervention: Drug: Pembrolizumab
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Publications * | Maubec E, Boubaya M, Petrow P, Beylot-Barry M, Basset-Seguin N, Deschamps L, Grob JJ, Dreno B, Scheer-Senyarich I, Bloch-Queyrat C, Leccia MT, Stefan A, Saiag P, Grange F, Meyer N, de Quatrebarbes J, Dinulescu M, Legoupil D, Machet L, Dereure O, Zehou O, Montaudie H, Wierzbicka-Hainaut E, Le Corre Y, Mansard S, Guegan S, Arnault JP, Dalac S, Aubin F, Alloux C, Lopez I, Cherbal S, Tibi A, Levy V; Groupe de Cancerologie Cutanee30. Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. J Clin Oncol. 2020 Sep 10;38(26):3051-3061. doi: 10.1200/JCO.19.03357. Epub 2020 Jul 30. | ||||||
* 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 | Completed | ||||||
Actual Enrollment ICMJE |
57 | ||||||
Original Estimated Enrollment ICMJE |
39 | ||||||
Actual Study Completion Date ICMJE | December 15, 2020 | ||||||
Actual Primary Completion Date | March 23, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 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 | France | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02883556 | ||||||
Other Study ID Numbers ICMJE | P151202 2016-002076-28 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |