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Metastatic Non-small Cell Lung CancerPhase 2NCT03679767

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

A Phase 2 study testing Retifanlimab in people with Metastatic Non-small Cell Lung Cancer and Locally Advanced Urothelial Cancer, run by Incyte Corporation at 52 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Retifanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
52 sitesin 8 countries
Study dates
9 Jan 2019to 28 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

52 sites in 8 countries.

52 sites in 8 countries

United States18 sites

  • New York Oncology Hematology - Albany

    Albany, New York, 12208

  • Texas Oncology Surgical Specialists - Austin Central

    Austin, Texas, 78731

  • Rcca Md, Llc

    Bethesda, Maryland, 20817

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • Rocky Mountain Cancer Centers - Denver - Midtown

    Denver, Colorado, 80218

  • VA New Jersey Health Care System

    East Orange, New Jersey, 07018

  • California Cancer Associates for Research and Excellence, Inc.

    Fresno, California, 93720

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93720

  • Christiana Care Helen F. Graham Cancer Center

    Newark, Delaware, 19718

  • AIM Trials, LLC

    Plano, Texas, 75093

  • Kaiser Permanente

    Portland, Oregon, 97227

  • Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

  • California Cancer Associates for Research and Excellence, Inc.

    San Marcos, California, 92069

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • St. Joseph Health Medical Group - Annadel Medical Group

    Santa Rosa, California, 95403

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    The Woodlands, Texas, 77380

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Wytheville, Virginia, 24382

Other trials in United States

Romania7 sites

  • Medisprof SRL

    Cluj-Napoca, 400461

  • Clinical Emergency Hospital of Constanta

    Constanța, 900591

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, Dolj, 200347

  • Oncolab SRL

    Craiova, Dolj, 200385

  • Center of Oncology Euroclinic

    Iași, 700106

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Oncocenter - Oncologie Clinica SRL

    Timișoara, 300166

Other trials in Romania

Spain7 sites

  • Centro Oncologico De Galicia

    A Coruña, 08041

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08025

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Puerta De Hierro

    Majadahonda, 28220

  • Hospital Universitari Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitari La Fe

    Valencia, 46026

Other trials in Spain

France5 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Institut Paoli Calmettes

    Marseille, 13009

  • CEPCM / CHU Timone

    Marseille, 13885

  • Georges Pompidou European Hospital

    Paris, 75015

  • Hopitaux Universitaires De Strasbourg

    Strasbourg, 67091

Other trials in France

Italy5 sites

  • Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • ASST Istituti Ospitalieri

    Cremona, 26100

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

Other trials in Italy

Austria4 sites

  • LKH Graz

    Graz

  • Medizinische Universitat Innsbruck

    Innsbruck, A-6020

  • Ordensklinikum

    Linz, 4010

  • Universitatsklinikum St. Polten

    Sankt Pölten, 3100

Other trials in Austria

Poland4 sites

  • Specjalistyczna Praktyka Lekarska

    Lublin, 20-093

  • BioVirtus Research Site

    Otwock, 05-400

  • Med-Polonia Sp. z o. o.

    Poznan, Greater Poland Voivodeship

  • Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

    Warsaw, Masovian Voivodeship

Other trials in Poland

Hungary2 sites

  • BAZ County Hospital

    Miskolc, 3526

  • Hetenyi G Korhaz, Onkologiai Kozpont

    Szolnok, 5004

Other trials in Hungary

About this study

Official title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

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.

Being tested
Retifanlimab
Keywords
PD-1inhibitor, non-small cell lung cancer, urothelial cancer, melanoma, renal cell carcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Melanoma, Clear-cell metastatic renal cell carcinoma, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Also called INCMGA00012

    Retifanlimab administered intravenously at 500 mg every 4 weeks

Study groups in NCT03679767
Study groupRoleWhat they receive
Melanoma: retifanlimab 500 mgExperimentalParticipants 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.
Receives: Drug: Retifanlimab
NSCLC: retifanlimab 500 mgExperimentalParticipants 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.
Receives: Drug: Retifanlimab
UC: retifanlimab 500 mgExperimentalParticipants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
Receives: Drug: Retifanlimab
RCC: retifanlimab 500 mgExperimentalParticipants 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.
Receives: Drug: Retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 25.9 months

Secondary outcomes (13)

  1. Duration of Response (DOR)

    DOR was defined as the time from initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by the investigator, 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.

    Measured: up to 24.0 months

  2. Disease Control Rate (DCR)

    DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. 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.

    Measured: up to 25.9 months

  3. 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, determined by investigator assessment, or death due to any cause, if occurring sooner than progression.

    Measured: up to 25.9 months

  4. 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.

    Measured: up to 28.2 months

  5. 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 therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of 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 until the earlier of 90 days of the last administration of retifanlimab and new anti-cancer therapy start if any, are reported.

    Measured: up to approximately 2.3 years

  6. First-dose Cmax of Retifanlimab

    Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.

    Measured: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1

  7. Cmax of Retifanlimab at Steady-state

    Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.

    Measured: 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)

  8. First-dose Tmax of Retifanlimab

    tmax was defined as the time to the maximum concentration of retifanlimab.

    Measured: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1

  9. Tmax of Retifanlimab at Steady-state

    tmax was defined as the time to the maximum concentration of retifanlimab.

    Measured: 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)

  10. First-dose Cmin of Retifanlimab

    Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.

    Measured: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1

  11. Cmin of Retifanlimabv at Steady-state

    Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.

    Measured: 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)

  12. First-dose AUC0-t of Retifanlimab

    AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.

    Measured: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1

  13. AUC0-t of Retifanlimab at Steady-state

    AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of retifanlimab.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study start9 Jan 2019
  3. Primary completion15 Apr 2021
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679767
Sponsor's protocol ID
INCMGA 0012-203
Status last verified
Jul 2023
First submitted
19 Sep 2018
Last updated
21 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retifanlimab in people with Metastatic Non-small Cell Lung Cancer and Locally Advanced Urothelial Cancer, run by Incyte Corporation at 52 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Romania, Spain, France, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: up to 25.9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03679767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

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