International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Recruiting
Phase 3
Interventional Study
Squamous Cell Carcinoma of the Penis, Usual Type
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Institute of Cancer Research, United Kingdom · Other
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About This Trial
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable pot…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent
2. Measurable disease as determined by RECIST (version 1.1) criteria;
3. Histologically-proven squamous cell carcinoma of the penis,
4. Stage:
* any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
* any T, N2 (i.e. palpabl…
Contacts
US/Canada - InPACT DA for EA8134
(857)504-2900
CONTACT