Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin (CARSKIN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02883556|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Squamous Cell||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||November 23, 2018|
|Estimated Study Completion Date :||October 22, 2021|
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.
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
- 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
- Safety profile (NCI CTCAE v4.0) [ Time Frame: up to 28 months ]Advers event and serious adverse event status
- RR in PD-L1-positive patients [ Time Frame: 15 weeks ]To assess in the whole sample and in PD-L1 positive patients
- Disease Control Rate using RECIST and modified RECIST v.1.1 [ Time Frame: 15 weeks ]Controled by the radiological evaluation
- RR using modified RECIST 1.1 [ Time Frame: 15 weeks ]Controled by the radiological evaluation
- RR using RECIST and modified RECIST v.1.1 [ Time Frame: 24 weeks ]Controled by the radiological evaluation
- Best RR using RECIST and modified RECIST v.1.1 [ Time Frame: 24 months ]The best response was collected after all radiological evaluation completion
- Overall Survival (OS) [ Time Frame: up to 24 months ]Survival status
- Progression Free Survival by RECIST 1.1 and modified RECIST 1.1 [ Time Frame: up to 24 months ]Controled by the radiological evaluation
- Duration of response (DOR) by RECIST 1.1 and modified RECIST 1.1 [ Time Frame: up to 24 months ]Controled by the radiological evaluation
- Duration of control by RECIST 1.1 and modified RECIST 1.1 [ Time Frame: up to 24 months ]Controled by the radiological evaluation
- Time to disease progression by RECIST 1.1 and modified RECIST 1.1 [ Time Frame: up to 24 months ]Controled by the radiological evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883556
|Bobigny, France, 93000|
|Principal Investigator:||Eve MAUBEC, Pr||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Zahia Ben-Abdesselam, CP||Unité de Recherche clinique|