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MelanomaNCT00495066

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

A study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 9 sites in Brazil.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Melanoma
What is being tested?
Ipilimumab
Type of treatment
Injection or infusion
How many people
Not given
Where
9 sitesBrazil
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT):≤ 2.5 x Upper Limit of Normal (ULN) for subjects without liver metastasis ≤ 5 times for liver metastases
  • Bilirubin: ≤ 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
  • Men and women, at least 16 years of age
  • Prior treatment with an anti-Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) drug is allowed provided therapy was not discontinued to to drug-related toxicity
  • Women of childbearing potential (WOCBP) and their partners must use highly effective methods of birth control (double barrier, e.g, condom or diaphragm or cervical cap associated with spermicide or intrauterine device combined with another form of birth control) for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at Screening and within 24 hours prior to the start of investigational product
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile
  • Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Brazil9 sites

  • Fundacao Pio XI - Hospital De Cancer De Barretos

    Barretos, São Paulo, 14784-400

  • Instituto do Cancer do Ceara

    Fortaleza, Ceará, 60930-230

  • Amaral Carvalho hospital

    Jaú, São Paulo, 17210-120

  • Hospital Sao Lucas das PUCRS

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

  • Hospital Mae de Deus

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

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Instituto ÉTICA - AMO - Assistência Multidisciplinar em Oncologia

    Salvador, Estado de Bahia, 41950-610

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-900

  • Hospital Sao Jose - Beneficencia Portuguesa - Oncology Center

    São Paulo, São Paulo, CEP 01321-001

Other trials in Brazil

About this study

Official title: A Multicenter Treatment Protocol for Expanded Access Use of Ipilimumab (BMS-734016) Monotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma

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
Being tested
Ipilimumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpilimumabDrug

    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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2007 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00495066
Sponsor's protocol ID
CA184-045
Status last verified
May 2013
First submitted
29 Jun 2007
Last updated
3 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 34620702

  • 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.

    PubMed 25649350

  • 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.

    PubMed 24844912

  • 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.

    PubMed 24695685

Questions about this trial

What is this clinical trial studying?

A study testing Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 9 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00495066, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.

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