A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Squamous Cell Carcinoma of Anal Canal Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597295
• Other study ID #: INCMGA 0012-202
• Status: Completed
• Phase: Phase 2
• Start date: October 8, 2018
• Est. completion date: November 10, 2021

Study information

• Verified date: October 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 10, 2021
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Anal Canal

Intervention

Drug:
• Retifanlimab
Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Locations

Country	Name	City	State
Belgium	Zna Middelheim	Antwerp
Belgium	Hopital Erasme	Brussels
Denmark	Aarhus Universitets Hospital	Aarhus
Denmark	Herlev Og Gentofte Hospital	Herlev
Denmark	Vejle Hospital	Vejle
France	Centre Hospitalier Universitaire de Besancon	Besancon
France	CHU Hopital De La Timone	Marseille
France	Chu Hopital de La Timone	Marseille Cedex 5
France	Icm Montpellier	Montpellier Cedex 5
France	Hopital Universitaire Pitie-Salpetriere	Paris
France	Chu de Rennes - Hôpital Pontchaillou	Rennes Cedex 9
France	Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau	Saint Herblain Cedex
France	CHU Toulouse Hopital Rangueil	Toulouse
Germany	Asklepios Klinik Altona	Hamburg
Germany	University Medical Centre Hamburg-Eppendorf, Centre of Oncology	Hamburg
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona
Italy	Ospedale A. Perrino - Brindisi	Brindisi
Italy	A.O.U. Policlinico V. Emanuele G. Rodolico	Catania
Italy	Ospedale Degli Infermi - Faenza	Faenza
Italy	Irccs Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Niguarda Cancer Center	Milano
Italy	Aou Modena - Policlinico	Modena
Italy	Clinica La Maddalena	Palermo
Italy	Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore	Rome
Italy	IRCCS Casa Sollievo Della Sofferenza	San Giovanni Rotondo
Norway	Haukeland U Hospital Bergen	Bergen
Norway	Oslo U	Oslo
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital General Universitari Vall D Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Royal Marsden Hospital	Chelsea
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	St. James U Hospital	Leeds
United Kingdom	St. James Univ Hospital	Leeds
United Kingdom	Royal Free London Nhs Foundation Trust	London
United Kingdom	The Royal Marsden Nhs Foundation Trust - Chelsea	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Royal Marsden Hospital	Sutton
United Kingdom	Royal Cornwall Hospital, Sunrise Centre	Truro
United States	Texas Oncology-Baylor Charles A. Sammons	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Texas Oncology-McKinney	McKinney	Texas
United States	Maryland Oncology Hematology P.A.	Rockville	Maryland
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Ridley-Tree Cancer Center	Santa Barbara	California
United States	Renovatio Clinical	Spring	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Italy,  Norway,  Spain,  United Kingdom, 

References & Publications (1)

Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retif — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.	Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Secondary	Duration of Response (DOR)	DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.	up to 18.2 months
Secondary	Disease Control Rate (DCR)	DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.	Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Secondary	Progression-free Survival (PFS)	According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, as determined by ICR, or death due to any cause, if occurring sooner than progression.	up to 16.8 months
Secondary	Overall Survival	Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.	up to 28.2 months
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab.	up to 913 days
Secondary	Cmax of Retifanlimab	Cmax was defined as the maximum observed plasma concentration.	pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Secondary	Tmax of Retifanlimab	tmax was defined as the time to the maximum concentration.	pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Secondary	Cmin of Retifanlimab	Cmin was defined as the minimum observed plasma concentration over the dose interval.	pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Secondary	AUC0-t of Retifanlimab	AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.	pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6