A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
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| ClinicalTrials.gov Identifier: NCT03679767 |
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Recruitment Status :
Completed
First Posted : September 20, 2018
Results First Posted : May 10, 2022
Last Update Posted : August 5, 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 clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: Retifanlimab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 121 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203) |
| Actual Study Start Date : | January 9, 2019 |
| Actual Primary Completion Date : | April 15, 2021 |
| Actual Study Completion Date : | June 28, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Melanoma: retifanlimab 500 mg
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.
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Drug: Retifanlimab
Retifanlimab administered intravenously at 500 mg every 4 weeks
Other Name: INCMGA00012 |
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Experimental: NSCLC: retifanlimab 500 mg
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.
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Drug: Retifanlimab
Retifanlimab administered intravenously at 500 mg every 4 weeks
Other Name: INCMGA00012 |
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Experimental: UC: retifanlimab 500 mg
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.
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Drug: Retifanlimab
Retifanlimab administered intravenously at 500 mg every 4 weeks
Other Name: INCMGA00012 |
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Experimental: RCC: retifanlimab 500 mg
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.
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Drug: Retifanlimab
Retifanlimab administered intravenously at 500 mg every 4 weeks
Other Name: INCMGA00012 |
Primary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: up to 21.0 months ]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.
Secondary Outcome Measures :
- Duration of Response (DOR) [ Time Frame: up to 18.4 months ]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.
- Disease Control Rate (DCR) [ Time Frame: up to 21.0 months ]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.
- Progression-free Survival (PFS) [ Time Frame: up to 21.0 months ]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.
- Overall Survival [ Time Frame: up to 26.5 months ]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.
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 3 years ]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.
- First-dose Cmax of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
- Cmax of Retifanlimab at Steady-state [ Time Frame: 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) ]Cmax was defined as the maximum observed plasma or serum concentration of retifanlimab.
- First-dose Tmax of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]tmax was defined as the time to the maximum concentration of retifanlimab.
- Tmax of Retifanlimab at Steady-state [ Time Frame: 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) ]tmax was defined as the time to the maximum concentration of retifanlimab.
- First-dose Cmin of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
- Cmin of Retifanlimabv at Steady-state [ Time Frame: 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) ]Cmin was defined as the minimum observed plasma or serum concentration over the dose interval of retifanlimab.
- First-dose AUC0-t of Retifanlimab [ Time Frame: preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1 ]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.
- AUC0-t of Retifanlimab at Steady-state [ Time Frame: 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) ]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.
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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:
- 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.
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): NCT03679767
Locations
Show 52 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Mark Cornfeld, MD | Incyte Corporation |
Study Documents (Full-Text)
Documents provided by Incyte Corporation:
Documents provided by Incyte Corporation:
Study Protocol [PDF] June 23, 2021
Statistical Analysis Plan [PDF] June 23, 2021
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT03679767 |
| Other Study ID Numbers: |
INCMGA 0012-203 |
| First Posted: | September 20, 2018 Key Record Dates |
| Results First Posted: | May 10, 2022 |
| Last Update Posted: | August 5, 2022 |
| Last Verified: | July 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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PD-1inhibitor non-small cell lung cancer urothelial cancer melanoma renal cell carcinoma |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Non-Small-Cell Lung Melanoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Kidney Diseases Urologic Diseases Male Urogenital Diseases |