THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)
Treatment:
Treatment with the anti-CTLA-4 mAb Ipilimumab monotherapy of each patient in the scope of
this trial is defined as induction plus re-induction of eligible patients until 12 months
after first receipt of study medication
Induction phase:
Ipilimumab will be applied to melanoma patients according to the protocol of the completed
Medarex study MDX-010-20: Ipilimumab by IV infusion, 3 mg/kg, day 1 (Week 1), 22 (Week 4),
43 (Week 7), 64 (Week 10)
Re-induction:
Patients who progress following stable disease of ≥ 3 months duration starting from
diagnosis at week 12 tumor assessment or patients who have progressed following an initial
response (partial or complete) assessed at week 12 may be offered additional cycles of
therapy with the originally assigned treatment regimen until off-treatment criteria are met,
provided they meet re-treatment eligibility requirements. No patient will be re-treated if
they experience a Grade 3 or higher gastrointestinal or certain other immune-related adverse
events (irAE) (refer to section 5.2 and 5.3). No patient with disease progression following
the first cycle of study medication will be permitted to be re-treated with study
medication.
Examinations:
The disease will be assessed at baseline, after 12 weeks and for patients with stable
disease or better responses, thereafter every 12 weeks in the absence of PD with a maximum
of one year. Response evaluation will be done according to immune-related response criteria
(Wolchok et al., CCR 2009).
All patients who prematurely discontinued treatment due to a drug-related adverse event
prior to Week 12 (in the absence of disease progression) will return for all study visits
and procedures including Week 12 and, if appropriate, further re-staging assessments. Any
patient with documented progression at any scheduled re-staging visit and who will not
receive any re-induction will undergo no further re-staging visits.
Follow-up phase:
Survival will be assessed every 3 months after the final dose of Ipilimumab until the end of
the follow-up phase for the individual patient. FU phase for each subject is 1 year
following first treatment dose. End of study will be at recruitment finished plus 1 year
post start of treatment of last patient thus ensuring that 1 year survival rate can be
estimated.
Study duration:
End of study is 1 year post LPFV. Recruiting period for the ocular melanoma:
Period of recruiting 12-18 months Enrolment start date (FPI): QIII 2011 Enrolment finish
date (LPI): QI 2013 End of study: QI 2014
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Overall survival rate at 12 months defined as the rate of patients alive 12 months after the date from the first study treatment for complete study
alive 12 months after date from the first study drug adminstration
Yes
Dirk Schadendorf, Professor
Principal Investigator
University Hospital, Essen
Germany: Federal Institute for Drugs and Medical Devices
DeCOG -MM-PAL11
NCT01355120
October 2011
September 2013
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