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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

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 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

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 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.
Note: Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 14 days before the first dose of study drug.
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Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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