THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease

NCT01355120 | Completed Phase 2 DMC

• 1 other identifier: DeCOG -MM-PAL11
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 25

Brief Summary

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma. The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.

Conditions

Ocular Melanoma

Keywords

advanced ocular melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• safety and efficacy parameters

  12 months after date from the first study drug adminstration

• Efficacy according to immune-related response criteria (ir-RC) at any time during treatment

  12 months after date from the first study drug administration

• Efficacy according RECIST criteria

  12 months after date from the first study drug administration

• Progression free survival rate at 6 months

  6 months after date from the first study drug administration

• Overall survival at 1 year in the subgroups (cutaneous, uveal, mucosal)

  12 months after date from the first study drug administration

Study Arms (1)

a human immunoglobulin

EXPERIMENTAL

Four infusions (i.v.) of 3mg/kg Ipilimumab in week 1, week 4, week 7 and week 10

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

Ipilimumab monotherapy 3mg/kg by four infusion every 3 weeks

Also known as: Yervoy

a human immunoglobulin

Eligibility Criteria

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

You may qualify if:

• Patients meeting all of the following criteria will be considered for admission to the trial:
• Histologically proven ocular melanoma
• Measurable disease according to RECIST in unresectable stage III-IV
• Minimum age of 18 years,
• Able and willing to give valid written inform consent
• Patients with or without prior systemic treatment for advanced malignant melanoma are eligible .
• In case of systemic pre-treatment, an interval of at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy is mandatory as well as recovery from any clinically significant toxicity experienced during treatment is recommended. Prior treatment must be completed by the time of ipilimumab administration. Palliative radiation therapy outside of the brain or therapeutic radiation to the brain after the patient's condition is stabilized and systemic steroids required for the management of symptoms due to brain metastases is decreased to the lowest fixed dose possible and does not require the 28-day waiting period. Patient must have recovered from any acute toxicity associated with prior therapy.
• Expected survival of at least six months
• ECOG Performance Status 0, 1 or 2.
• Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:
• Lab Parameter Range White blood cells (WBC) \>= 2500/mm3 (≥ 1 2.5 x 109/L) Absolute neutrophil count (ANC) \>= 1000/mm3 (≥ 1.0 x 109/L) Platelets ≥75.000/mm3 (≥ 75 x 109/L) Hemoglobin ≥ 9 g/dL (≥ 90 g/L; may be transfused) Creatinine \<= 2.0 x ULN Bilirubin total \<= 2.0 x ULN (excepted patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) \<= 5 x ULN for patients with liver metastases
• No childbearing potential or negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
• Women of childbearing potential (WOCP) must be using an effective method of contraception (Pearl-Index \< 1, e.g. oral contraceptives, other hormonal contraceptives \[vaginal products, skin patches, or implanted or injectable products\], or mechanical products such as an intrauterine device or barrier methods \[diaphragm, spermicides\]) throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
• No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
• WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal.

You may not qualify if:

• Patients will be excluded from the study for any of the following reasons:
• The patient requires concomitant therapy with any of the following: IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; any other systemic therapy for cancer including any other experimental treatment.
• The patient requires chronic use of systemic corticosteroids. Systemic steroids for management of symptoms due to brain mets should be avoided if possible or subject should be stable on the lowest clinically effective dose. Topical or inhalational steroids are permitted.
• Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
• Active autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[eg, Wegener's Granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
• Symptomatic CNS metastases (Remark: Asymptomatic stable, untreated or pretreated central nervous system (CNS) metastasis are allowed)
• Family history of congenital or hereditary immunodeficiency.
• The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
• Lack of availability for clinical follow-up assessments.
• The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
• Patients with serious intercurrent illness, requiring hospitalization.
• For female patients: the patient is pregnant or lactating. Women of childbearing potential: Refusal or inability to use effective means of contraception
• Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.

Sponsors & Collaborators

• Prof. Dr. med. Dirk Schadendorf: lead

Study Sites (25)

Universitätsklinikum Erlangen Hautklinik

Erlangen, Bavaria, 91052, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, Bavaria, 90419, Germany

Location

Klinikum Kassel GmbH

Kassel, Hesse, 34125, Germany

Location

Klinikum Dorothea Christiane Erxleben Quedlinburg gGmbH

Quedlinburg, Saxony-Anhalt, 06484, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universitätsklinikum Klinik f.Dermatologie, Allegologie u.Venerologie

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charité Universitätsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Krankenhaus Buxtehude

Buxtehude, 21614, Germany

Location

Universitätsklinik Köln

Cologne, 50937, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

University Hospital Essen

Essen, 45122, Germany

Location

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Heidelberg Hautklinik

Heidelberg, 69115, Germany

Location

Universitätsklinikum des Saarlandes, Homburg

Homburg/Saar, 66421, Germany

Location

Klinik Universitätsklinikum Jena Klinik f. Hautkrankheiten

Jena, 07743, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Leipzig Dermatologie

Leipzig, 04103, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, 67063, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Mannheim gGmbH, Medizinische Fakultät Mannheim derUniversität Heidelberg

Mannheim, 68167, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Ludwig-Maximilians-Universität München

München, 80337, Germany

Location

Fachklinik Hornheide

Münster, 48157, Germany

Location

Universitätsklinikum Münster Klinik u.Poliklinik f.Hautkrankheiten

Münster, Germany

Location

Univ.-Klinikum Regensburg

Regensburg, 93053, Germany

Location

Universitätshautklinik Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (2)

• Zimmer L, Eigentler TK, Kiecker F, Simon J, Utikal J, Mohr P, Berking C, Kampgen E, Dippel E, Stadler R, Hauschild A, Fluck M, Terheyden P, Rompel R, Loquai C, Assi Z, Garbe C, Schadendorf D. Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanoma. J Transl Med. 2015 Nov 6;13:351. doi: 10.1186/s12967-015-0716-5.

  PMID: 26541511 DERIVED

• Zimmer L, Vaubel J, Mohr P, Hauschild A, Utikal J, Simon J, Garbe C, Herbst R, Enk A, Kampgen E, Livingstone E, Bluhm L, Rompel R, Griewank KG, Fluck M, Schilling B, Schadendorf D. Phase II DeCOG-study of ipilimumab in pretreated and treatment-naive patients with metastatic uveal melanoma. PLoS One. 2015 Mar 11;10(3):e0118564. doi: 10.1371/journal.pone.0118564. eCollection 2015.

  PMID: 25761109 DERIVED

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal 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

• Dirk Schadendorf, Professor

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: May 17, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: April 9, 2025

Record last verified: 2014-06

Locations

DE (25)