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

Phase 1

Conditions: Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of :a. NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.b. advanced or metastatic UC in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a CPS = 10.c. unresectable or metastatic melanoma.d. advanced or metastatic RCC with clear cell component and having received no prior systemic therapy
MedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864
MedDRA version: 21.0Level: LLTClassification code 10038395Term: Renal carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-002941-12-HU

Lead Sponsor: Incyte Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Men and women 18 years of age or older (or as applicable per local country requirements).
3. Confirmed diagnosis of one of the following:
a. Treatment-naïve metastatic NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.
b. Locally-advanced or metastatic UC in participants who are not eligible for cisplatin therapy (determined by the investigator) and whose tumors express PD-L1 with a CPS = 10.
c. Unresectable or metastatic melanoma.
d. Locally advanced or metastatic RCC with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy
4. Measurable disease per RECIST v1.1.
5. ECOG performance status 0 to 1.
6. Willingness to avoid pregnancy or fathering children as described in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
1. Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
2. Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
a. Adjuvant therapy that was completed = 12 months before study entry may be acceptable but should be discussed with the medical monitor before enrolling the participant on study.
3. Radiotherapy within 14 days of first dose of study treatment with the following caveats:
a. 28 days for pelvic radiotherapy.
b. 6 months for thoracic region radiotherapy that is > 30 Gy.
c. 14 days for palliative radiation therapy.
Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
4. 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.
5. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
6. Participants with laboratory values at screening as defined in Table 7 of the protocol.
7. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the
skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
8. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
a. Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
b. Participants with asthma that requires intermittent use of
bronchodilators, inhaled steroids, or local steroid injections may participate.
c. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
d. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment–related standard premedication are permitted.
9. Evidence of interstitial lung disease or active noninfectious pneumonitis.
10. Known active CNS metastases and/or carcinomatous meningitis.
11. Known active HBA, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
12. Active infections requiring systemic therapy.
13. Participants who are known to be HIV-positive, unless all of the following criteria are met:
a. CD4+ count = 300/µL, b. Undetectable viral load , c. Receiving highly active antiretroviral therapy.
14. Known hypersensitivity to another mAb that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
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Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of INCMGA00012 in terms of the ORR in tumor types of interest.;Secondary Objective: To determine the DOR , DCR, PFS, OS, safety, and PK of INCMGA00012<br><br>;Primary end point(s): ORR, defined as the percentage of participants having a CR or PR, according to RECIST v1.1 as determined by the investigator.;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): DOR, defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause.<br>DCR, defined as the proportion of participants with either an objective response<br>PFS, defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause.<br>OS, defined as the time from the start of therapy until death due to any cause.<br>Safety, determined by the number of participants, frequency, duration, and severity of AEs, laboratory tests, vital signs, and ECGs.<br>The PK of INCMAG00012 including Cmax, tmax, Cmin, and AUCt, will be summarized.;Timepoint(s) of evaluation of this end point: Throughout the study

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