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Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma

ConditionMelanoma (Skin)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, Irvine

About this trial

This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.

Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have > 1 RECIST measurable lesion.

Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.

Life expectancy of at least 12 weeks.

Disqualifiers

Participants with visceral, bone, or brain metastases.

Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.

Participants with N1a or N2a only disease.

Participants with a diagnosis of acral, ocular or mucosal melanoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fianlimab

    Drug

    Given IV

  • Cemiplimab

    Drug

    Given IV

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: 3 doses of neoadjuvant of Fianlimab in combination with CemiplimabExperimental treatment 2 interventions
Group B: 6 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental treatment 2 interventions
Group C: 8 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Major Pathologic Response (MPR) Rate by RECIST v1.1

Evaluate the major pathologic response (MPR), defined as pathologic complete response (pCR) + pathologic near complete response (pnCR) after treatment with dual checkpoint blockade in the index lymph node of Cohort 2 and Cohort 3

Time frame
16 months
2

Major Pathologic Response (MPR) Rate by RECIST v1.1

Evaluate the MPR rate in the primary cutaneous melanoma site after wide local excision (if wide local excision was deferred after diagnostic biopsy)

Time frame
16 months

Secondary outcomes

1

Major Pathologic Response (MPR) Rate by RECIST v1.1

Evaluate the major pathologic response (MPR), defined as pathologic complete response (pCR) + pathologic near complete response (pnCR) in Cohort 1.

Time frame
16 months
2

Objective Response Rate (ORR) by RECIST v1.1

Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.

Time frame
16 months
3

Event-Free Survival (EFS)

Determine the event-free survival (EFS) for each cohort. EFS is measured from the date of randomization to the first date of any of the following occurrences: disease progression that preclude surgery, toxicity from neoadjuvant treatment that precludes surgery, inability to surgically resect the primary lesion or undergo TLND, disease progression, toxic effects of adjuvant treatment if indicated, surgical complications, melanoma recurrence after surgery during the follow up period, or death from any cause.

Time frame
28 months
4

Number of Patients with Adverse Events

Number of Patients who received at least one dose of Fianlimab with Cemiplimab with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

Time frame
28 months

Other outcomes

Sponsors and contacts

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

University of California, Irvine

Lead sponsor

UC Cancer Consortium

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: