Unresectable locally advanced or metastatic penile squamous cell carcinoma (PSqCC). MedDRA version: 20.0 Level: PT Classification code 10034299 Term: Penile cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: INCMGA00012
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: INCMGA00012
Other descriptive name: INCMGA00012
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
Medica Scientia Innovation Research (MedSIR)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the following inclusion criteria to be eligible for enrolment into the study: • Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities. • Male patients = 18 years of age at the time of signing ICF.• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. • Life expectancy =12 weeks. • Histologically-proven PSqCC. • Locally advanced unresectable or metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1). • Radiological evidence of locally advanced or metastatic disease. • Patients must have measurable disease or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria.• • Willingness and ability to provide blood samples (liquid biopsy) at the time of inclusion, after 2 cycles of study treatment (C3D1), and upon PD or study termination. • Adequate organ function: • Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 75.0 x109/L, and hemoglobin > 9.0 g/dL. • Hepatic: Bilirubin = 1.5 times the upper limit of normal (× ULN) ( 2.5 mg/mL. • Serum creatinine = 1.5 x ULN; alternately measured or calculated creatinine clearance =30 mL/min with creatinine levels >1.5 × institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance). • Coagulation: Activated Partial Thromboplastin Time (aPTT) =1.5 X ULN and International Normalized Ratio (INR) orProthrombin Time (PT) =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.• Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study treatment. • Patients that have received prior chemotherapy regimens or radiotherapy for locally recurrent and/or metastatic disease are not excluded but patients nai¨ve of systemic treatment can also be included. • For pretreated patients, last dose of chemotherapy administered = 28 days from study entry. 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Locally PSqCC candidate for curative treatment. 2. Prior therapy with an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent. 3. Known hypersensitivity to any of the excipients of INCMGA00012. 4. Receipt of anticancer therapy or participation in another interventional clinical study within 28 days before the first administration of study drug; 6 weeks for mitomycin C. 5. Radiotherapy within 14 days of first dose of study treatment with the following caveat: 28 days for pelvic radiotherapy. 6. Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with Sponsor’s medical monitor. 7. Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of study drug, or patients who have not recovered from the side effects of any major surgery, or patients who may require major surgery during the study. 8. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated (e.g., radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. 9. Metabolic: Uncontrolled hyper/hypothyroidism or diabetes mellitus type 1 (T1DM). Patients with hypothyroidism stable on hormone replacement will not be excluded from the trial. Patients with controlled T1DM on a stable insulin regimen may be eligible for this study. 10. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or immunosuppressive therapy within seven days prior to study treatment initiation. 11. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic steroid replacement therapy (= 10 mg prednisone daily) for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 12. Prior allogenic stem cell or solid organ transplantation. 13. Has received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live- attenuated vaccines and are not allowed. 14. Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease. 15. Active uncontrolled infection at the time of screening. 16. Latent tuberculosis determined by a positive TST followed by confirmation by pulmonologists. 17. Participants who are known to be human immunodeficiency virus (HIV)-positive, unless all of the following criteria are met: a. CD4-positive count = 300/µL; b. Undetectable viral load; c. Receiving highly active antiretroviral therapy. 18. Active hepatitis A virus (HAV) (positivity for HAV IgM antibody), hepatitis B virus (HBV) (patients with n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy –as determined by the objective response rate (ORR)– of INCMGA00012 in patients with unresectable locally advanced or metastatic PSqCC.;Secondary Objective: . To assess the efficacy –as determined by clinical benefit rate (CBR), the progression-free survival (PFS), the 6-month progression-free survival (PFS), duration of response (DoR), time to progression (TTP), overall survival (OS), and maximum tumor shrinkage– of INCMGA00012 in these patients. . To evaluate the safety and tolerability of INCMGA00012 in these patients.;Primary end point(s): Primary endpoint: • The efficacy will be evaluated by investigator-assessed RECIST response.;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • The efficacy will be evaluated by CBR, PFS, 6-month PFS, DoR, TTP, OS, and maximum tumor shrinkage. • The safety and tolerability will be evaluated by incidence of adverse events (AEs), incidence of prespecified AEs, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results. Exploratory endpoints: • ORR, CBR and 6-month PFS as per irRECIST. • Relationship between tumor- and/or immune-related biomarkers, and efficacy in tumor tissue and/or liquid biopsy. • Changes from baseline in the CD4-positive cell count and HIV viral load in participants who are known to be HIV-positive.;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression. | — |
Countries
Spain
Contacts
Public ContactMarta Martínez de Falcón
Medica Scientia Innovation Research (MedSIR)
Outcome results
None listed