Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) (ORPHEUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04231981|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : August 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Penile Cancer||Drug: INCMGA0012||Phase 2|
Men age ≥ 18 years with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1) that are presenting with radiologic progression of disease (PD) following or not standard treatment with chemotherapy.
After signing the ICF and confirmed eligibility, patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle, once every four weeks for up to 2 years.
Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months (± 14 days) from the last dose of investigational product until the end of study (EoS).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, open-label, single-arm|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma.|
|Actual Study Start Date :||April 28, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Interventional arm
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.
INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
- Objective response rate (ORR) [ Time Frame: Baseline up to 24 months ]The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.
- Efficacy determined by Clinical Benefit Rate (CBR) [ Time Frame: Baseline up to 24 months ]CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set.
- Efficacy determined by Progression-free survival (PFS) [ Time Frame: Baseline up to 24 months ]PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.
- Efficacy determined by 6-months PFS [ Time Frame: Baseline up to 6 months ]6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.
- Efficacy determined by Duration of Response (DoR) [ Time Frame: Baseline up to 24 months ]DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1.
- Efficacy determined by Overall survival (OS) [ Time Frame: Baseline up to 24 months ]OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive.
- Efficacy determined by maximum tumor shrinkage [ Time Frame: Baseline up to 24 months ]Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria v1.1.
- Safety adverse events (AEs) [ Time Frame: Baseline up to 24 months ]Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events [SAEs]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
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): NCT04231981
|IRCCS Ospedale San Raffaele|
|Milano, Italy, 20132|
|Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.|
|AUSL Reggio Emilia|
|Reggio Emilia, Italy|
|Hospital de la Santa Creu i Sant Pau|
|Hospitalet de Llobregat, Spain|
|Hospital 12 de octubre|
|Hospital Clínico San Carlos|
|Hospital Virgen de la Arrixaca|
|Hospital Universitari Son Espases|
|Palma De Mallorca, Spain|
|Hospital Insular de Gran Canaria|
|Palmas de Gran Canaria, Spain|
|Hospital Virgen del Rocío|
|Instituto Valenciano de Oncología|
|Hospital Miguel Servet|
|Principal Investigator:||Xavier García del Muro||ICO- Hospitalet|