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Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy

ConditionsCutaneous Squamous Cell CarcinomaSkin Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cosibelimab

    Drug

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

  • Prednisone

    Drug

    Corticosteroid, per standard of care

  • Sirolimus

    Drug

    mTOR Inhibitor, per standard of care

  • Everolimus

    Drug

    mTOR Inhibitor, per standard of care

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort A: Cosibelimab + Standard of Care Immunosuppressive RegimenExperimental treatment 4 interventions
Group B: Cohort B: CosibelimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 102 weeks.

Secondary outcomes

1

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.

Time frame
Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
2

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.

Time frame
Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
3

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.

Time frame
Up to 51 weeks.
4

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Checkpoint Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov
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