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A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

ConditionsAdvanced Renal Cell Carcinoma (aRCC)Metastatic Renal Cell Carcinoma ( mRCC)Clear Cell Renal Cell Carcinoma (ccRCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrian Rini

About this trial

This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent.

Karnofsky Performance Status ≥ 70% within 14 days prior to registration.

Histological or cytological evidence of renal cell carcinoma having a clear cell component

Disqualifiers

Prior systemic therapy against renal cell carcinoma in the neo/adjuvant or metastatic setting

Any condition requiring ongoing ≥ 10 mg prednisone equivalent/day

Participants with a history of myocarditis.

If clinically indicated based on clinical assessment and any ECG abnormalities, optional troponin T (TnT) or troponin I (TnI) may be done as described in the protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fianlimab

    Drug

    Fianlimab will be co-administered by IV.

  • Ipilimumab

    Drug

    Ipilimumab will be administered by IV.

  • Nivolumab

    Drug

    Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.

  • Cemiplimab

    Drug

    Cemiplimab will co-administered by IV.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Arm A: Cemiplimab, Fianlimab, and IpilimumabExperimental treatment 3 interventions
Group B: Arm B: Cemiplimab and FianlimabExperimental treatment 2 interventions
Group C: Arm C: Nivolumab and IpilimumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.

Time frame
2 years

Secondary outcomes

1

Median Progression Free Survival (PFS)

PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

Time frame
5 years
2

12-month Progression Free Survival (PFS)

PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

Time frame
12 months
3

24-month Progression Free Survival (PFS)

PFS is defined as the time from Day 1 of treatment to the first documented disease progression per RECIST 1.1, clinically progressive disease per investigator, or death due to any cause, whichever occurs first.

Time frame
24 months
4

Duration of Response (DOR)

DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 until disease progression based on RECIST 1.1 or death due to any cause, whichever occurs first.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Brian Rini

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Regeneron Pharmaceuticals

Collaborator

Vanderbilt-Ingram Cancer Center

Collaborator

Source ClinicalTrials.gov
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