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.
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
Drug | Synonyms | Arms |
---|
carboplatin | | Group A : carboplatin+paclitaxel+placebo |
paclitaxel | | Group A : carboplatin+paclitaxel+placebo |
retifanlimab | INCMGA00012 | Group 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
Name | Type | Description | Interventions |
---|
Group A : carboplatin+paclitaxel+placebo | Placebo Comparator | Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle | |
Group B : carboplatin+paclitaxel+retifanlimab | Experimental | Participants 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
July 29, 2021