A Phase II, Open-Labeled, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma
- Conditions
- Recurrent or Metastatic (R/M) Cutaneous Squamous Cell Carcinoma (cSCC)MedDRA version: 20.0Level: PTClassification code 10041834Term: Squamous cell carcinoma of skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000594-37-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
1.All participants must have cSCC that is either metastatic defined as disseminated disease, and/or unresectable disease that is not curable by surgery, radiation, or systemic therapy
2.Be at least 18 years of age on the day of signing the informed consent
3.Participants must have histologically-confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary is not permitted)
4.Participants must have metastatic disease defined as disseminated disease distant to the initial/primary site of diagnosis, and/or must have locally recurrent disease that has been previously treated (with either surgery, radiotherapy, or systemic therapy), and is no t amenable to either curative surgery, radiotherapy, or concurrent chemo-radiotherapy treatment
5.Participants must have had prior treatment with either a platinum containing regimen or a cetuximab containing regimen. Treatment with at least one or the othe r is required; treatment with both is not required
6.Participants must have measurable disease based on RECIST 1.1 as assessed by the central imaging vendor. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
7.Participants must have e an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of treatment
8.Participants must have adequate organ function as defined in the protocol.Specimens must be collected within 10 days prior to the start of trial treatment
9.Participants must have a tissue sample adequate for PD-L1 testing as determined by central laboratory testing prior to trial allocation. This tissue sample may be obtained from either a newly obtained core or excisional biopsy, or a prior archival tissue specimen
10.Participants must have a life expectancy of greater than 3 months
11. A male participant of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.3.4 of the protocol. Contraception, and detailed in Appendix 5 of this protocol, during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
12.Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
13.A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies: a)Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the protocol, b)A WOCBP who agrees to use an adequate method of contraception as outlined in Section 6.3.4 of the protocol. Contraception, and detailed in Appendix 5 of this protocol, during the treatment period and for at least 120 days after the last dose of study treatment
14.The participant (or legally acceptable representative if applicable) must be willing and able to provide written informed consent for the trial. The participant may also provide consent for Future Biomedical Research. However the participant may participate in the main trial without participating in Future Biomedical Research
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects f
1.Participant has cSCC that is amenable to surgical resection, local control with radiotherapy, or local control with a combination of surgery and radiotherapy, or chemoradiotherapy
2.Participant has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen’s disease, MCC, melanoma
3.Participants with any prior allogeneic solid organ or bone marrow transplantation are excluded
4.Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T cell receptor (eg, CTLA-4, OX-40, CD137)
5.Participant has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
6.Participant has received prior radiotherapy within 2 weeks of start of trial treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease
7.Participant has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killedvirus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live- attenuated vaccines and are not allowed
8.Participant is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment
9.Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug
10 Participant has a known additional malignancy that is progressing or has required active treatment within the past 5 years
11.Participant has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment
12.Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (eg, with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
13.Participant has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
14.Participant has an active infection requiring systemic therapy
15.Participant has a known history of human immunodeficiency virus (HIV) infection
16.Participant has a known history of Hepatitis B (defined as Hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method