Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

NCT00495066 | Unknown

• 1 other identifier: CA184-045
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.

Conditions

Melanoma

Interventions

Ipilimumab DRUG

Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; Until disease progression, unacceptable toxicity or withdrawal of consent

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent
• Histologically confirmed Stage III (unresectable) or Stage IV melanoma
• Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. Note: Enrollees must not be eligible for a clinical study with Ipilimumab
• Subjects with asymptomatic brain metastases are eligible
• Primary ocular and mucosal melanomas are allowed
• Must be at least 28 days since treatment with chemotherapy, biochemotherapy, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment. Must have recovered from prior surgery or radiation. Systemic corticosteroids should be eliminated or weaned to the minimum dose before starting Ipilimumab treatment. Consult with the Medical Monitor for individual subjects
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0- 2
• Life expectancy ≥ 16 weeks
• Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, and pelvis. Bone scans should be completed if clinically indicated. The images can be accepted if obtained 6 weeks before initiation of Ipilimumab
• Required values for initial laboratory tests:
• White Blood Cells (WBC): ≥ 2000/uL (≥ 2 x 10\*9\*/L)
• Antigen Neutrophil Count (ANC): ≥ 1000/uL (≥ 1 x 10\*9\*/L)
• Platelets: ≥ 75 x 103/uL (≥ 75 x 10\*9\*/L)
• Hemoglobin: ≥ 9 g/dL (≥ 80 g/L; may be transfused)
• Creatinine: ≤ 2.0 x ULN

You may not qualify if:

• Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 12 weeks after the last dose of investigational product
• WOCBP using a prohibited contraceptive method
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or before investigational product administration
• Subjects on any other systemic therapy for cancer, including any other experimental treatment
• Prior treatment with an anti CTLA 4 antibody if treatment failure was due to Immune-Related Adverse Events (irAEs) or discontinuation was due to an Adverse Event (AE)/Serious Adverse Event (SAE)
• Any subject enrolled in a registrational study (ie, CA184024) that has a survival endpoint should not be enrolled in CA184-045. Also, if a subject is eligible for a treatment study, he or she is not eligible for this study
• Presence of active autoimmune disease
• Presence of known hepatitis B or hepatitis C (active) infection, regardless of control on antiviral therapy
• Any subject who has a life threatening condition that requires high-dose immunosuppressants
• Subjects with melanoma who have another active, concurrent, malignant disease, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
• Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of Ipilimumab, with the exceptions of Amantadine and Flumadine
• Any subject enrolled in a registrational study (ie, CA184-024) that has a survival as a primary endpoint should not be enrolled in CA184-045. Also, if a subject is eligible for a treatment study, he or she is not eligible for this study
• Subjects from studies CA184-042, CA184-078 or CA184-087, who are being followed for survival only or for scans only are not eligible for this study

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Instituto do Cancer do Ceara

Fortaleza, Ceará, 60930-230, Brazil

Location

Instituto ÉTICA - AMO - Assistência Multidisciplinar em Oncologia

Salvador, Estado de Bahia, 41950-610, Brazil

Location

Instituto Nacional de Cancer - INCA

Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

Location

Hospital Sao Lucas das PUCRS

Porto Alegre, Rio Grande Do Sul (RS), 90610-000, Brazil

Location

Hospital Mae de Deus

Porto Alegre, Rio Grande Do Sul (RS), 90840440, Brazil

Location

Fundacao Pio XI - Hospital De Cancer De Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Amaral Carvalho hospital

Jaú, São Paulo, 17210-120, Brazil

Location

Hospital A. C. Camargo

São Paulo, São Paulo, 01509-900, Brazil

Location

Hospital Sao Jose - Beneficencia Portuguesa - Oncology Center

São Paulo, São Paulo, CEP 01321-001, Brazil

Location

Related Publications (4)

• Koguchi Y, Iwamoto N, Shimada T, Chang SC, Cha J, Curti BD, Urba WJ, Piening BD, Redmond WL. Trough levels of ipilimumab in serum as a potential biomarker of clinical outcomes for patients with advanced melanoma after treatment with ipilimumab. J Immunother Cancer. 2021 Oct;9(10):e002663. doi: 10.1136/jitc-2021-002663.

  PMID: 34620702 DERIVED

• Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

  PMID: 25649350 DERIVED

• Kitano S, Postow MA, Ziegler CG, Kuk D, Panageas KS, Cortez C, Rasalan T, Adamow M, Yuan J, Wong P, Altan-Bonnet G, Wolchok JD, Lesokhin AM. Computational algorithm-driven evaluation of monocytic myeloid-derived suppressor cell frequency for prediction of clinical outcomes. Cancer Immunol Res. 2014 Aug;2(8):812-21. doi: 10.1158/2326-6066.CIR-14-0013. Epub 2014 May 20.

  PMID: 24844912 DERIVED

• Iwama S, De Remigis A, Callahan MK, Slovin SF, Wolchok JD, Caturegli P. Pituitary expression of CTLA-4 mediates hypophysitis secondary to administration of CTLA-4 blocking antibody. Sci Transl Med. 2014 Apr 2;6(230):230ra45. doi: 10.1126/scitranslmed.3008002.

  PMID: 24695685 DERIVED

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

BR (9)