Clinical trial for Cutaneous Squamous Cell Carcinoma
Official title Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
ClinicalTrials.gov ID: NCT07426484
What this study is testing
What is Cosibelimab?
Cosibelimab is an investigational anti‑PD‑L1 antibody being studied as a potential treatment for advanced cutaneous squamous cell carcinoma. It is designed to block the PD‑L1 protein, which may help the immune system recognize and attack cancer cells.
Also referred to as CK-301, Cosibelimab‑ipdl, UNLOXCYT.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new drug called cosibelimab works well. It also checks how safe the drug is for these specific groups.
- Who it's for
- You may be able to join if you have advanced skin cancer. You must also have a kidney transplant or a blood cancer.
- What's involved
- You would get cosibelimab, which is a type of antibody medicine. The team will watch you closely to see how your body reacts.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment).
- COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent...
- Chronic lymphocytic leukemia (CLL)
- Small cell lymphocytic lymphoma (SLL)
- Follicular lymphoma (FL)
You likely can't join if
- 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...
- Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g.
- Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory...
- Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone \>10mg daily (or equivalent), anti-CD20 antibodies...
- 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.
See the full eligibility criteria
Who can 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).
- 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)
- Chronic myelogenous leukemia (CML)
- Polycythemia vera (PV)
- Primary myelofibrosis
- Essential thrombocythemia (ET)
- Chronic neutrophilic leukemia
- Chronic eosinophilic leukemia
- 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...
- 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...
- 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.
- 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).
- Absolute neutrophil count ≥1.0 K/mcL
- Platelets ≥30 K/mcL
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), except people 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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).
- 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...
- 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.
- 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.
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the study drug are excluded.
- History of organ transplant other than kidney, including a heart, lung, or liver transplant, etc, with the exception of cornea transplantation.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.