Clinical Trials Logo
  1. Home
  2. Melanoma
  3. NCT00289627
  4. Details
NCT00289627 Clinical Trial

A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Melanoma Clinical Trial

Official title:
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00289627
Other study ID # CA184-008
Secondary ID
Status Completed
Phase Phase 2
First received February 9, 2006
Last updated September 27, 2016
Start date April 2006
Est. completion date July 2007

Study information
Verified date September 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

Locations
Country Name City State
Austria Local Institution Salzburg
Austria Local Institution Wels
Austria Local Institution Wien
Finland Local Institution Turku
Italy Local Institution Genova
Italy Local Institution Meldola
Italy Local Institution Milano
Italy Local Institution Napoli
Italy Local Institution Padova
Italy Local Institution Siena
Italy Local Institution Torino
Norway Local Institution Oslo
Poland Local Institution Lodz
Poland Local Institution Poznan
Poland Local Institution Wroclaw
Russian Federation Local Institution Barnaul
Russian Federation Local Institution Moscow
Russian Federation Local Institution Murmansk
Russian Federation Local Institution Ryazan
Russian Federation Local Institution Samara
Russian Federation Local Institution St Petersburg
Russian Federation Local Institution St. Petersburg
Russian Federation Local Institution Stavropol
Russian Federation Local Institution Velikiy Novgorod
Russian Federation Local Institution Voronezh
Spain Local Institution Barcelona
Spain Local Institution Madrid
Spain Local Institution Malaga
Spain Local Institution Tenerife
Spain Local Institution Valencia
Sweden Local Institution Goteborg
Sweden Local Institution Lund
Sweden Local Institution Stockholm
Sweden Local Institution Uppsala
Ukraine Local Institution Cherkassy
Ukraine Local Institution Dnipropetrovsk
Ukraine Local Institution Kiev
Ukraine Local Institution Lvov
Ukraine Local Institution Sumy
Ukraine Local Institution Uzhgorod

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Medarex

Countries where clinical trial is conducted

United States,  Austria,  Finland,  Italy,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary estimate disease control rate
Secondary estimate progression free survival rate at Week 12
Secondary estimate PFS
Secondary estimate overall survival
Secondary estimate survival rate at one year
Secondary estimate duration of BOR
Secondary evaluate proportion of patients whose duration of response is >=24 weeks
Secondary estimate time to BOR
Secondary evaluate safety profile of ipilimumab during the induction and maintenance phases
Secondary evaluate health-related quality of life
Secondary obtain PK sample for population PK analysis
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT03979872 - Risk Information and Skin-cancer Education for Undergraduate Prevention N/A
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05077137 - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy Phase 1
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05839912 - Excision of Lymph Node Trial (EXCILYNT) (Mel69) N/A
Recruiting NCT04971499 - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma Phase 1/Phase 2
Recruiting NCT05263453 - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation Phase 2
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06413680 - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies Phase 1/Phase 2
Completed NCT03348891 - TNF in Melanoma Patients Treated With Immunotherapy N/A
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Not yet recruiting NCT05539118 - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma Phase 1/Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn NCT02854488 - Yervoy Pregnancy Surveillance Study

External Links