CompletedPhase 2

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

Italy, Spain18 participantsStarted 2020-04-28

Plain-language summary

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Locally PSqCC candidate for curative treatment.
✕. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
✕. Known hypersensitivity to any of the excipients of INCMGA00012.
✕. 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.
✕. Radiotherapy within 14 days of first dose of study treatment with the following caveat: 28 days for pelvic radiotherapy.
✕. 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.
✕. 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.
✕. 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.

What they're measuring

Objective Response Rate (ORR)

Timeframe: From baseline until disease progression or treatment discontinuation, up to 10.3 months

Trial details

NCT IDNCT04231981

SponsorMedSIR

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-15

Results submitted2023-03-15

View on ClinicalTrials.gov More Penile Cancer trials