Recruiting

Cosibelimab

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07426484

Conditions

Cutaneous Squamous Cell Carcinoma

Skin Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cosibelimab

Prednisone

Sirolimus

Everolimus

Study Details

Brief 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)

Conditions

Cutaneous Squamous Cell Carcinoma

Skin Cancer

Study ID

NCT07426484

Start date

Apr 23, 2026

Status verified date

Aug, 2026

Completion date

Dec 15, 2032

Anticipated

Primary completion date

Dec 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: Cosibelimab + Standard of Care Immunosuppressive Regimen

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

experimental: Cohort B: Cosibelimab

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

Interventions

Cosibelimab

Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol

Prednisone

Corticosteroid, per standard of care

Sirolimus

mTOR Inhibitor, per standard of care

Everolimus

mTOR Inhibitor, per standard of care

Primary outcome measure

  • Best Overall Response Rate (BORR) [ Time Frame: Up to 102 weeks. ]

Central Contacts and Locations

Central contacts

Ann Silk, MD

617-632-6836Ann_Silk@dfci.harvard.edu

Ann Silk, MD

617-632-6836CosiMaster@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ann Silk, MD

617-632-6836Ann_Silk@dfci.harvard.edu

CosiMaster@dfci.harvard.edu

Principal Investigator:

Ann Silk, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ann Silk, MD

617-632-6836Ann_Silk@dfci.harvard.edu

CosiMaster@dfci.harvard.edu

Principal Investigator:

Ann Silk, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-11.