Clinical trial NCT03679767: A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
Official title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-09-20
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
* 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.
* Has received a live vaccine within 28 days of the planned start of study drug.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: up to 25.9 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: up to 24.0 months
measure: Disease Control Rate (DCR)
timeFrame: up to 25.9 months
measure: Progression-free Survival (PFS)
timeFrame: up to 25.9 months
measure: Overall Survival
timeFrame: up to 28.2 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to approximately 2.3 years
measure: First-dose Cmax of Retifanlimab
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: Cmax of Retifanlimab at Steady-state
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
measure: First-dose Tmax of Retifanlimab
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: Tmax of Retifanlimab at Steady-state
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
measure: First-dose Cmin of Retifanlimab
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: Cmin of Retifanlimabv at Steady-state
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
measure: First-dose AUC0-t of Retifanlimab
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: AUC0-t of Retifanlimab at Steady-state
timeFrame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days)
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence, Inc.
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research and Excellence, Inc.
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Health Medical Group - Annadel Medical Group
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver - Midtown
state: Colorado
city: Newark
country: United States
facility: Christiana Care Helen F. Graham Cancer Center
state: Delaware
city: Bethesda
country: United States
facility: Rcca Md, Llc
state: Maryland
city: East Orange
country: United States
facility: VA New Jersey Health Care System
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology - Albany
state: New York
city: Portland
country: United States
facility: Kaiser Permanente
state: Oregon
city: Austin
country: United States
facility: Texas Oncology Surgical Specialists - Austin Central
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Northeast
state: Texas
city: The Woodlands
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Wytheville
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Graz
country: Austria
facility: LKH Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Linz
country: Austria
facility: Ordensklinikum
city: St. Polten
country: Austria
facility: Universitatsklinikum St. Polten
city: Bordeaux
country: France
facility: Institut Bergonié
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: CEPCM / CHU Timone
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Strasbourg
country: France
facility: Hopitaux Universitaires De Strasbourg
city: Miskolc
country: Hungary
facility: BAZ County Hospital
city: Szolnok
country: Hungary
facility: Hetenyi G Korhaz, Onkologiai Kozpont
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona
city: Cremona
country: Italy
facility: ASST Istituti Ospitalieri
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Warszawa
country: Poland
facility: Centrum Onkologii- Instytut im Marii Skłodowskiej Curie
state: Mazowieckie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o. o.
state: Wielkopolskie
city: Lublin
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Otwock
country: Poland
facility: BioVirtus Research Site
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
state: Dolj
city: Craiova
country: Romania
facility: Oncolab SRL
state: Dolj
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Constanta
country: Romania
facility: Clinical Emergency Hospital of Constanta
city: Iasi
country: Romania
facility: Center of Oncology Euroclinic
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Timisoara
country: Romania
facility: Oncocenter - Oncologie Clinica SRL
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
city: A Coruna
country: Spain
facility: Centro Oncologico De Galicia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta De Hierro
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
Study officials:
affiliation: Incyte Corporation
name: Mark Cornfeld, MD
role: STUDY_DIRECTOR
References: