A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
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| ClinicalTrials.gov Identifier: NCT03597295 |
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Recruitment Status :
Completed
First Posted : July 24, 2018
Results First Posted : August 23, 2021
Last Update Posted : January 20, 2022
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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Brief Summary:
The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Squamous Cell Carcinoma of Anal Canal | Drug: Retifanlimab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 94 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202) |
| Actual Study Start Date : | October 8, 2018 |
| Actual Primary Completion Date : | June 8, 2020 |
| Actual Study Completion Date : | November 10, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: INCMGA00012 |
Drug: Retifanlimab
INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
Other Names:
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Primary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: Cycle 1 day 1, and every 4 weeks throughout the study, up to approximately 24 months. ]Defined as Complete Response (CR),- Disappearance of all target lesions; Partial Response (PR)->=30% decrease in the sum of the longest diameter (LD) of target lesions from baseline; Overall Response (OR) = CR + PR, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by independent central radiographic review (ICR)
Secondary Outcome Measures :
- Duration of Response [ Time Frame: Up to approximately 3 years ]The time measurement from initial objective response Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions), as per RECIST v1.0, until the first date that disease progression is determined by ICR or death.
- Disease Control Rate [ Time Frame: Up to approximately 3 years ]The number of participants with a confirmed overall response of CR, PR, or SD, as per RECIST 1.1, at any postbaseline visit until the first PD or start of new anticancer therapy.
- Progression-free Survival [ Time Frame: Up to approximately 3 years ]According to RECIST 1.1, PFS is defined as the length of time from initial infusion of study drug until the earliest date of disease progression, determined by ICR, or death due to any cause, if occurring sooner than progression.
- Overall Survival [ Time Frame: Up to approximately 3 years ]Overall survival is defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
- Number of Treatment-emergent Adverse Events [ Time Frame: Up to approximately 3 years ]Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
- Cmax of INCMGA00012 [ Time Frame: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6 ]Maximum observed plasma concentration
- Tmax of INCMGA00012 [ Time Frame: Preinfusion, 10 minutes post-infusion D1C6 ]Time to maximum concentration.
- Cmin of INCMGA00012 [ Time Frame: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6 ]Minimum observed plasma concentration over the dose interval.
- AUC0-t of INCMGA00012 [ Time Frame: Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes post-infusion and 4 hrs post-infusion on D1C1 and D1C6 ]Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Cycle 1 and Cycle 6: Day 1 predose and 10 min and 4 h after infusion Cycles 2, 4, and 7: Day 1 predose
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to comprehend and willingness to sign a written informed consent form.
- Confirmed diagnosis of locally advanced or metastatic SCAC.
- Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
- Must have measurable disease by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
Exclusion Criteria:
- Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
- Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
- Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
- Active autoimmune disease requiring systemic immunosuppression.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known active hepatitis infection.
- Active infections requiring systemic therapy.
- Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597295
Locations
Show 47 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Incyte Medical Monitor | Incyte Corporation |
Study Documents (Full-Text)
Documents provided by Incyte Corporation:
Documents provided by Incyte Corporation:
Study Protocol [PDF] July 8, 2019
Statistical Analysis Plan [PDF] October 17, 2019
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT03597295 |
| Other Study ID Numbers: |
INCMGA 0012-202 |
| First Posted: | July 24, 2018 Key Record Dates |
| Results First Posted: | August 23, 2021 |
| Last Update Posted: | January 20, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Incyte Corporation:
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Squamous carcinoma of the anal canal anti-PD-1 antibody IgG4 monoclonal antibody INCMGA00012 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |