Clinical Trials /

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429

Description:

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

Related Conditions:
  • Anal Canal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
  • Official Title: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-303
  • NCT ID: NCT04472429

Conditions

  • Squamous Cell Carcinoma of the Anal Canal

Interventions

DrugSynonymsArms
carboplatinGroup A : carboplatin+paclitaxel+placebo
paclitaxelGroup A : carboplatin+paclitaxel+placebo
retifanlimabINCMGA00012Group B : carboplatin+paclitaxel+retifanlimab

Purpose

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

Trial Arms

NameTypeDescriptionInterventions
Group A : carboplatin+paclitaxel+placeboPlacebo ComparatorParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
  • carboplatin
  • paclitaxel
Group B : carboplatin+paclitaxel+retifanlimabExperimentalParticipants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
  • carboplatin
  • paclitaxel
  • retifanlimab

Eligibility Criteria

        Inclusion Criteria:

          -  Able to comprehend and willing to sign a written ICF for the study.

               -  Are 18 years of age or older (or as applicable per local country requirements).

               -  Histologically or cytologically verified, inoperable locally recurrent or
                  metastatic SCAC.

               -  No prior systemic therapy other than the following: a. Chemotherapy administered
                  concomitantly with radiotherapy as a radiosensitizing agent is permitted.

                  b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study
                  entry.

               -  Has measurable disease per RECIST v1.1 as determined by local site
                  investigator/radiology assessment. Tumor lesions situated in a previously
                  irradiated area, or in an area subjected to other loco-regional therapy, are
                  usually not considered measurable unless there has been demonstrated progression
                  in the lesion.

               -  Able and willing to provide adequate tissue sample and whole blood sample with
                  central testing result prior to randomization. Biopsy for archival samples should
                  have occurred within 6 months prior to randomization.

               -  ECOG performance status 0 to 1.

               -  If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 300/μL, b.
                  Undetectable viral load per standard of care assay, c. Receiving antiretroviral
                  therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not
                  experienced any HIV-related opportunistic infection for at least 4 weeks prior to
                  study enrollment.

               -  Willingness to avoid pregnancy or fathering children

        Exclusion Criteria:

          -  Has received prior PD-(L)1 directed therapy

          -  Has received prior radiotherapy with or without radiosensitizing chemotherapy within
             28 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to
             Grade ≤ 1).

          -  Participants with laboratory outside of the protocol defined ranges.

          -  History of second malignancy within 3 years (with exceptions).

          -  Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.

          -  Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.

          -  Receipt of a live vaccine within 28 days of planned start of study therapy.

          -  History of organ transplant, including allogeneic stem cell transplantation.

          -  Known active CNS metastases and/or carcinomatous meningitis.

          -  Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of
             the excipients that cannot be controlled with standard measures (eg, antihistamines,
             corticosteroids).

          -  Participant is pregnant or breastfeeding.

          -  Current use of protocol defined prohibited medication.

          -  Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.

          -  Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
             requirements
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:up to 4.5 years
Safety Issue:
Description:Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 4.5 years
Safety Issue:
Description:Defined as the time from the date of randomization until death due to any cause.
Measure:Overall Response Rate (ORR)
Time Frame:Up to 4.5 years
Safety Issue:
Description:Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
Measure:Duration of Response (DOR)
Time Frame:Up to 4.5 years
Safety Issue:
Description:Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.
Measure:Disease Control Rate(DCR)
Time Frame:Up to 4.5 years
Safety Issue:
Description:Defined as the number of participants maintaining either an ORR or stable disease.
Measure:Number of treatment-emergent adverse events
Time Frame:Up to 4.5 years
Safety Issue:
Description:Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Measure:Cmax of retifanlimab when administered with chemotherapy
Time Frame:Up to 4.5 years
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:tmax of retifanlimab when administered with chemotherapy
Time Frame:Up to 4.5 years
Safety Issue:
Description:Time to maximum concentration
Measure:Cmin of retifanlimab when administered with chemotherapy
Time Frame:Up to 4.5 years
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval
Measure:AUC0-t of retifanlimab when administered with chemotherapy
Time Frame:Up to 4.5 years
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Squamous cell carcinoma
  • carboplatin
  • paclitaxel
  • PD-1 Inhibitor
  • Anal Cancer
  • SCAC

Last Updated

June 11, 2021