CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Conditions

Melanoma

Brief summary

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

Anuradha Ratna, Shyamali Mukherjee, Salil K. Das

Cancer Science & Research2021-12-30

10.33425/2639-8478.1079

Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status.

Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R.

2019-04-1217 citations

10.1111/cts.12633

A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab

Philip Friedlander, Kevin Wood, Karl Wassmann, Alan M. Christenfeld, Nina Bhardwaj et al. (6 authors)

Journal for ImmunoTherapy of Cancer2018-09-1848 citations

10.1186/s40425-018-0408-9

Correlation of consistent blood-based gene expression with change in CTLA4 in two large independent clinical studies of patients with advanced melanoma treated with tremelimumab.

Philip Friedlander, Karl Wassman, Chrisann Kyi, William Oh, Nina Bhardwaj

Journal of Clinical Oncology2017-03-012 citations

10.1200/jco.2017.35.7_suppl.6

Tremelimumab, a fully human anti-CTLA-4 monoclonal antibody, optimal dosing regimen for patients with unresectable malignant mesothelioma (MM).

Rajesh Narwal, Alessandra DiPietro, Ramy Ibrahim, Luana Calabrò, Michele Maio et al. (7 authors)

Journal of Clinical Oncology2015-05-203 citations

10.1200/jco.2015.33.15_suppl.3042

Interventions

DRUGdacarbazine

decarbazine 1000 mg/m2 IV Q 21 days x 12

DRUGCP-675,206

CP-675,206 15 mg/kg IV Q 90 days x 4

DRUGtemozolomide

temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions. * Serum lactic acid dehydrogenase (LDH) \<= 2 x ULN * ECOG performance status of 0 or 1

Exclusion criteria

* Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma. * History of brain metastases

Design outcomes

Primary

Measure	Time frame
overall survival	August 2010

Secondary

Measure	Time frame
PFS at 6 months	6 months
objective tumor response	1 year
Durable response	6 months
pharmacokinetics endpoints	15 months
adverse events	1 year
HQol	1 year
healthcare resource utilization and loss of productivity	1 year
human antihuman antibody response for patients in Arm A	15 months
pharmacogenomic endpoints	1 year

Countries

Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

Outcome results

None listed