A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy
- Conditions
- Squamous Carcinoma Anal canal (SCAC) - Anal Cancer1000211210027476
- Registration Number
- NL-OMON48162
- Lead Sponsor
- Incyte Biosciences Benelux B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 2
Male and female participants at least 18 years of age with locally advanced or
metastatic SCAC who have progressed after platinum-based chemotherapy.
According to Protocol version 4, dated 08-Jul-2019 an update of the criteria:
a Prior 2 lines of systemic therapy for metastatic disease are permitted.
b Participants who are ineligible for platinum must have received at least 1
prior line of systemic therapy.
c. Participants receiving platinum-based radiosensitizing chemotherapy are
eligible if relapse occurs within 6 months from completion of treatment.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall Response Rate, defined as the percentage of participants having a CR<br /><br>(complete response) or PR (partial response), according to RECIST v1.1 as<br /><br>determined by ICR (Independent Central Radiographic Review)</p><br>
- Secondary Outcome Measures
Name Time Method