Cutaneous Squamous Cell CarcinomaPhase 4NCT07426484
Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
A Phase 4 study testing Cosibelimab, Prednisone and Sirolimus in people with Cutaneous Squamous Cell Carcinoma and Skin Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). The name of the drug involved in this research study is: -cosibelimab (a type of an anti-PD-L1 antibody) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Skin Cancer
- What is being tested?
- Cosibelimab, Prednisone and Sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Apr 2026to 15 Dec 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.)
- COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM).
- Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to:
- Chronic lymphocytic leukemia (CLL)
- Small cell lymphocytic lymphoma (SLL)
- Follicular lymphoma (FL)
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- Lymphoplasmacytic lymphoma
- Waldenström macroglobulinemia
- Marginal zone lymphoma
- Mantle cell lymphoma, indolent variety
- Cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome)
- Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to:
- Chronic myelogenous leukemia (CML)
- Polycythemia vera (PV)
- Primary myelofibrosis
- Essential thrombocythemia (ET)
- Chronic neutrophilic leukemia
- Chronic eosinophilic leukemia
- Examples of myeloma, including but not limited to:
- Multiple myeloma (MM)
- Smoldering myeloma
- Participants must have histologically or cytologically confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC).
- Note: Mixed histology is acceptable (e.g. basosquamous, squamous cell carcinoma with adnexal differentiation), and other histologic variants (sarcomatoid carcinoma, spindle cell carcinoma, poorly differentiated carcinoma with squamous features).
- Participant must have CSCC that is not amenable to surgery or radiation therapy, or recurrent despite prior surgery or radiation therapy, including locally advanced unresectable CSCC for which local therapy (surgery and/or radiation therapy) is not recommended. This includes CSCC occurring in patients who are not surgical candidates due to comorbidities and patients who refuse surgery (due to concerns about morbidity, disfigurement, etc).
- Participants must have measurable disease as per PET Response Criteria in Solid Tumors version
- (PERCIST 1.0),46 defined as any tumor (of any size) whose SUV lean (SUL) peak is greater than 1.5 times the mean SUL in the liver + 2 times its standard deviation. Mean SUL in the liver is measured in a 3-cm diameter spherical volume of interest (VOI), which is a measurement of the SUV background.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of cosibelimab in participants <18 years of age, children are excluded from this study.
- ECOG performance status 0-2 (see Appendix A for definitions of this and Karnofsky Performance Status).
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥1.0 K/mcL
- Platelets ≥30 K/mcL
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL
- AST(SGOT) ≤ 2.5 × institutional ULN
- ALT(SGPT) ≤ 2.5 × institutional ULN
- Adequate renal function, defined as defined as estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
- Serum creatinine ≤ 3.0 x institutional ULN or ≤ 3.0 x baseline (grade ≤ 2 per CTCAE)
- Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- PD-1 and PD-L1 immune checkpoint antibodies are classified as pregnancy class D. For this reason, and because other therapeutic agents used in this trial are potentially teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 120 days after completion of cosibelimab administration. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 120 days after completion of cosibelimab administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.
- Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)
- Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.
- Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone >10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).
- Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.
- Participants who are receiving any other investigational agents for cancer within 2 weeks of study enrollment.
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- Participants who have uncontrolled, symptomatic infections, or infections requiring systemic antibiotics (prophylactic antimicrobials are permitted).
- Participants who have uncontrolled or unstable brain metastases (or other CNS metastases) for whom systemic steroids are required. These patients are excluded because steroids may interfere with the effectiveness of immune checkpoint therapy.
- Uncontrolled or significant cardiovascular disease.
- Current need for dialysis (hemodialysis or peritoneal dialysis).
- History of stem cell transplant or bone marrow transplant
- Psychiatric illness or social situation that would preclude study compliance.
- Pregnant and breastfeeding women are excluded from this study because cosibelimab is classified as pregnancy class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cosibelimab, breastfeeding should be discontinued if the mother is treated with cosibelimab.
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study drug are excluded.
- COHORT A ONLY:
- History of organ transplant other than kidney, including a heart, lung, or liver transplant, etc, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.
- History of severe allergic reaction attributed to sirolimus or everolimus, or other absolute contraindication to mTOR inhibitor, as determined by the treating physician.
- COHORT B ONLY: History of any solid organ transplant, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ann Silk, MD, 617-632-6836, Ann_Silk@dfci.harvard.edu
CosiMaster@dfci.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ann Silk, MD, 617-632-6836, Ann_Silk@dfci.harvard.edu
CosiMaster@dfci.harvard.edu
About this study
Official title: A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)
This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC).
The name of the drug involved in this research study is:
-cosibelimab (a type of an anti-PD-L1 antibody)
Read the detailed description
This is a Phase IV, multi-site, multi-cohort, open-label clinical trial investigating the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). Checkpoint Therapeutics is supporting this research study by providing the study drug, cosibelimab.
Participants will be enrolled into one of two study groups: Group A or Group B.
Cosibelimab is FDA-approved for the treatment of advanced cutaneous squamous cell carcinoma
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, or Positron Emission (PET) scans, electrocardiograms (ECGs), Tumor biopsies and aspirations.
It is expected that about 80 people will take part in this research study.
- Conditions
- Cutaneous Squamous Cell Carcinoma, Skin Cancer
- Being tested
- Cosibelimab, Prednisone, Sirolimus, Everolimus
- Keywords
- Advanced Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Skin Cancer, Kidney Transplant Recipient, Chronic lymphocytic leukemia (CLL), Myeloma, Waldenstrom macroglobulinemia, Solid Organ Transplant Recipient, Immunosuppressed, Lymphoma
- Medical subject headings
- Skin Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms, Plasma Cell, Waldenstrom Macroglobulinemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosibelimabDrug
Also called CK-301, Cosibelimab-ipdl, UNLOXCYT
Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol
PrednisoneDrug
Corticosteroid, per standard of care
SirolimusDrug
mTOR Inhibitor, per standard of care
EverolimusDrug
mTOR Inhibitor, per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen | Experimental | 40 Kidney transplant recipients with advanced CSCC will be enrolled and will complete the following-
* Baseline visit
* Cycle 1 through Cycle 17 (21-day cycle)
* Day 1: Predetermined dose Cosibelimab 1x daily.
* Day 1 through 21: pre-determined dose of Prednisone 1X daily
* Day 1 through 21: determined dose of sirolimus or everolimus 1X daily
* Follow-up every three months
* Long-term follow-up Receives: Drug: Cosibelimab; Drug: Prednisone; Drug: Sirolimus; Drug: Everolimus |
| Cohort B: Cosibelimab | Experimental | 40 Participants with co-diagnosis of hematologic malignancy/myeloproliferative disorder and advanced CSCC will be enrolled and will complete-
* Baseline visit
* Cycle 1 through Cycle 17 (21-day cycle)
--Day 1: Predetermined dose Cosibelimab 1x daily.
* Follow-up every three months
* Long-term follow-up Receives: Drug: Cosibelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (BORR)
BORR is defined as the proportion of participants whose best overall responses are complete metabolic response (CMR) and partial metabolic response (PMR). Per PERCIST 1.0 for target lesions, CMR is visual disappearance of all metabolically active tumor, and PMR is at least a 30% decrease in SUL peak (minimum 0.8-unit decrease) in the lesion with greatest uptake, not necessarily the same lesion.
Measured: Up to 102 weeks.
Secondary outcomes (8)
Treatment-Emergent Adverse Events (TEAEs) Rate
TEAEs rate is defined as the proportion of participants who experience one or more adverse events that emerge or worsen after the initiation of study treatment.
Measured: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Immune-related Adverse Events (AE) Rate
The immune-related AE rate is defined as the proportion of participants who experience at least one adverse event considered by the investigator to be immune-related during the study treatment period.
Measured: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Allograft Rejection and Allograft Loss Rate in Cohort A
Allograft rejection loss rate is defined as the proportion of participants in Cohort A who experience allograft rejection or allograft loss, as determined by elevated serum creatinine, urine protein levels, donor-derived cell-free DNA (dd-cfDNA), renal biopsy findings, or the need for renal replacement therapy.
Measured: Up to 51 weeks.
Median Progression-Free Survival (PFS)
PFS is defined as the time from registration to the earlier of progressive metabolic disease (PMD), as defined by PERCIST 1.1, or death from any cause. PFS will be estimated using the Kaplan-Meier method. Participants who are alive without documented disease progression at the time of analysis will be censored at the date of their last disease evaluation.
Measured: Tumor assessments will be performed before Cycle 3, 5 Day 1 (28-day cycles) and every 4 cycles through Cycle 17. Follow-up assessments will occur on Cycle 18, 21, 29, and 33 Day 1.
Duration of Response (DOR)
DOR, defined according to PERCIST 1.1, is measured using the Kaplan-Meier method from the first documentation of complete metabolic response (CMR) or partial metabolic response (PMR), whichever occurs first, to the earliest date of objectively documented recurrent or progressive metabolic disease (PMD), using the lowest recorded measurements since treatment initiation as the reference, or death from any cause. Participants without documented events will be censored at the date of their last disease evaluation.
Measured: 2 years
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as time from date of first dose until the date of death due to any cause. Participants are censored as date last known alive.
Measured: Up to 147 weeks
Median Disease Specific Survival (DSS)
DSS based on Kaplan-Meier method is defined as the time from study enrollment to death specifically due to advanced cutaneous squamous cell carcinoma (CSCC). Deaths from other causes are censored at the time of occurrence.
Measured: Up to 102 weeks.
Median Circulating Tumor DNA (ctDNA) Levels
ctDNA will be assessed from plasma using a personalized mPCR-NGS-based assay (Signatera™). ctDNA levels will be quantified as mean tumor molecules per milliliter of plasma (MTM/mL).
Measured: Up to 102 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start23 Apr 2026
- Primary completion15 Dec 2030 (estimated)
- Study completion15 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Checkpoint Therapeutics, Inc.
- Responsible party
- Principal investigator, Ann W. Silk, MD MS, Dana-Farber Cancer Institute
- Investigators
- Ann Silk, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426484
- Sponsor's protocol ID
- 25-743
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)
- ClinicalTrials.gov ID
- NCT07426484
- Acronym / sponsor ID
- 25-743
- Conditions
- Cutaneous Squamous Cell Carcinoma, Skin Cancer
- Keywords
- Advanced Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Skin Cancer, Kidney Transplant Recipient, Chronic lymphocytic leukemia (CLL), Myeloma, Waldenstrom macroglobulinemia, Solid Organ Transplant Recipient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Checkpoint Therapeutics, Inc.
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 15 Dec 2032 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC).
The name of the drug involved in this research study is:
-cosibelimab (a type of an anti-PD-L1 antibody)
Detailed description
This is a Phase IV, multi-site, multi-cohort, open-label clinical trial investigating the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). Checkpoint Therapeutics is supporting this research study by providing the study drug, cosibelimab.
Participants will be enrolled into one of two study groups: Group A or Group B.
Cosibelimab is FDA-approved for the treatment of advanced cutaneous squamous cell carcinoma
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, or Positron Emission (PET) scans, electrocardiograms (ECGs), Tumor biopsies and aspirations.
It is expected that about 80 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen | Experimental | Drug: Cosibelimab, Drug: Prednisone, Drug: Sirolimus, Drug: Everolimus40 Kidney transplant recipients with advanced CSCC will be enrolled and will complete the following- * Baseline visit * Cycle 1 through Cycle 17 (21-day cycle) * Day 1: Predetermined dose Cosibelimab 1x daily. * Day 1 through 21: pre-determined dose of Prednisone 1X daily * Day 1 through 21: determined dose of sirolimus or everolimus 1X daily * Follow-up every three months * Long-term follow-up |
| Cohort B: Cosibelimab | Experimental | Drug: Cosibelimab40 Participants with co-diagnosis of hematologic malignancy/myeloproliferative disorder and advanced CSCC will be enrolled and will complete- * Baseline visit * Cycle 1 through Cycle 17 (21-day cycle) --Day 1: Predetermined dose Cosibelimab 1x daily. * Follow-up every three months * Long-term follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.)
- COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM).
- Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to:
- Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to:
- Examples of myeloma, including but not limited to:
Key exclusion criteria (18 listed)
- Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.
- Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)
- Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.
- Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone >10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).
- Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CosibelimabAlso: CK-301, Cosibelimab-ipdl, UNLOXCYTAnti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol | Drug | Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen, Cohort B: Cosibelimab |
| PrednisoneCorticosteroid, per standard of care | Drug | Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen |
| SirolimusmTOR Inhibitor, per standard of care | Drug | Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen |
| EverolimusmTOR Inhibitor, per standard of care | Drug | Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen |
Primary outcome
Best Overall Response Rate (BORR)
Time frame: Up to 102 weeks.
BORR is defined as the proportion of participants whose best overall responses are complete metabolic response (CMR) and partial metabolic response (PMR). Per PERCIST 1.0 for target lesions, CMR is visual disappearance of all metabolically active tumor, and PMR is at least a 30% decrease in SUL peak (minimum 0.8-unit decrease) in the lesion with greatest uptake, not necessarily the same lesion.
8 secondary outcomes
Treatment-Emergent Adverse Events (TEAEs) Rate
Time frame: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Immune-related Adverse Events (AE) Rate
Time frame: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Allograft Rejection and Allograft Loss Rate in Cohort A
Time frame: Up to 51 weeks.
Median Progression-Free Survival (PFS)
Time frame: Tumor assessments will be performed before Cycle 3, 5 Day 1 (28-day cycles) and every 4 cycles through Cycle 17. Follow-up assessments will occur on Cycle 18, 21, 29, and 33 Day 1.
Duration of Response (DOR)
Time frame: 2 years
Median Overall Survival (OS)
Time frame: Up to 147 weeks
Median Disease Specific Survival (DSS)
Time frame: Up to 102 weeks.
Median Circulating Tumor DNA (ctDNA) Levels
Time frame: Up to 102 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Silk, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cosibelimab, Prednisone and Sirolimus in people with Cutaneous Squamous Cell Carcinoma and Skin Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Silk, MD (617-632-6836, Ann_Silk@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate (BORR) (time frame: Up to 102 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.