A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

NCT03679767 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCMGA 0012-203
• Study Type: interventional
• Target: 121
• Locations: 8 countries
• Sites: 52

Brief Summary

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

Conditions

Metastatic Non-small Cell Lung Cancer; Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer; Unresectable Melanoma; Metastatic Melanoma; Locally Advanced Renal Cell Carcinoma; Metastatic Clear-Cell Renal Cell Carcinoma

Keywords

PD-1inhibitor; non-small cell lung cancer; urothelial cancer; melanoma; renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall 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 determined by the investigator, 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.

  up to 25.9 months

Secondary Outcomes (13)

• Duration of Response (DOR)

  up to 24.0 months

• Disease Control Rate (DCR)

  up to 25.9 months

• Progression-free Survival (PFS)

  up to 25.9 months

• Overall Survival

  up to 28.2 months

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  up to approximately 2.3 years

Study Arms (4)

Melanoma: retifanlimab 500 mg

EXPERIMENTAL

Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.

Drug: Retifanlimab

NSCLC: retifanlimab 500 mg

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Drug: Retifanlimab

UC: retifanlimab 500 mg

EXPERIMENTAL

Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Drug: Retifanlimab

RCC: retifanlimab 500 mg

EXPERIMENTAL

Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.

Drug: Retifanlimab

Interventions

Retifanlimab DRUG

Retifanlimab administered intravenously at 500 mg every 4 weeks

Also known as: INCMGA00012

Melanoma: retifanlimab 500 mg; NSCLC: retifanlimab 500 mg; RCC: retifanlimab 500 mg; UC: retifanlimab 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy.
• Measurable disease per RECIST v1.1.
• Eastern Cooperative Oncology Group performance status 0 to 1.
• Willingness to avoid pregnancy or fathering children.

You may not qualify if:

• Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
• Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
• 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.
• Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
• Laboratory values outside the protocol-defined range at screening.
• Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
• Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent).
• Evidence of interstitial lung disease or active noninfectious pneumonitis.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
• Active infections requiring systemic therapy.
• Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
• Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
• Impaired cardiac function or clinically significant cardiac disease.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (52)

California Cancer Associates for Research and Excellence, Inc.

Fresno, California, 93720, United States

Location

California Cancer Associates for Research and Excellence

Fresno, California, 93720, United States

Location

California Cancer Associates for Research and Excellence, Inc.

San Marcos, California, 92069, United States

Location

St Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

St. Joseph Health Medical Group - Annadel Medical Group

Santa Rosa, California, 95403, United States

Location

Rocky Mountain Cancer Centers - Denver - Midtown

Denver, Colorado, 80218, United States

Location

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, 19718, United States

Location

Rcca Md, Llc

Bethesda, Maryland, 20817, United States

Location

VA New Jersey Health Care System

East Orange, New Jersey, 07018, United States

Location

New York Oncology Hematology - Albany

Albany, New York, 12208, United States

Location

Kaiser Permanente

Portland, Oregon, 97227, United States

Location

Texas Oncology Surgical Specialists - Austin Central

Austin, Texas, 78731, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78404, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Texas Oncology - San Antonio Northeast

San Antonio, Texas, 78217, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

The Woodlands, Texas, 77380, United States

Location

Texas Oncology - Waco

Waco, Texas, 76712, United States

Location

Oncology & Hematology Associates of Southwest Virginia, Inc.

Wytheville, Virginia, 24382, United States

Location

LKH Graz

Graz, Austria

Location

Medizinische Universitat Innsbruck

Innsbruck, A-6020, Austria

Location

Ordensklinikum

Linz, 4010, Austria

Location

Universitatsklinikum St. Polten

Sankt Pölten, 3100, Austria

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

CEPCM / CHU Timone

Marseille, 13885, France

Location

Georges Pompidou European Hospital

Paris, 75015, France

Location

Hopitaux Universitaires De Strasbourg

Strasbourg, 67091, France

Location

BAZ County Hospital

Miskolc, 3526, Hungary

Location

Hetenyi G Korhaz, Onkologiai Kozpont

Szolnok, 5004, Hungary

Location

Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

ASST Istituti Ospitalieri

Cremona, 26100, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

Istituto Nazionale Tumori Regina Elena

Rome, 00144, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Med-Polonia Sp. z o. o.

Poznan, Greater Poland Voivodeship, Poland

Location

Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

Warsaw, Masovian Voivodeship, Poland

Location

Specjalistyczna Praktyka Lekarska

Lublin, 20-093, Poland

Location

BioVirtus Research Site

Otwock, 05-400, Poland

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, Dolj, 200347, Romania

Location

Oncolab SRL

Craiova, Dolj, 200385, Romania

Location

Medisprof SRL

Cluj-Napoca, 400461, Romania

Location

Clinical Emergency Hospital of Constanta

Constanța, 900591, Romania

Location

Center of Oncology Euroclinic

Iași, 700106, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, 550245, Romania

Location

Oncocenter - Oncologie Clinica SRL

Timișoara, 300166, Romania

Location

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Centro Oncologico De Galicia

A Coruña, 08041, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08025, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

Location

Hospital Puerta De Hierro

Majadahonda, 28220, Spain

Location

Hospital Universitari La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Clear-cell metastatic renal cell carcinoma; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Mark Cornfeld, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: January 9, 2019
• Primary Completion: April 15, 2021
• Study Completion: June 28, 2022
• Last Updated: July 21, 2023
• Results First Posted: May 10, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); HU (2); RO (7); PL (4); AU (4); US (18); ES (7); IT (5)