A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2

NCT01480323 | Completed Phase 2 DMC

• 1 other identifier: 5027000
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The current clinical trial shall clarify a synergistic effect with regards to efficiency by the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous application of ipilimumab.

Conditions

Malignant Melanoma

Keywords

Malignant melanoma

Outcome Measures

Primary Outcomes (1)

• Control rate

  To determine efficacy of the combined treatment with ipilimumab and intratumoral IL-2 by assessment of Disease control rate according to immune-related response criteria (irDCR) at week 12

  at week 12

Secondary Outcomes (10)

• Tolerability

  within 12 months after start of treatment

• Overall survival

  within 12 months after start of treatment

• Best Overall Response Rate

  within 12 months after start of treatment

• Overall response rate

  at week 12

• Overall Response Rate

  at week 12

Study Arms (1)

Ipilimumab

EXPERIMENTAL

Ipilimumab i.v. + Interleukin-2 intratumoral

Drug: Interleukin-2; Drug: Ipilimumab

Interventions

Interleukin-2 DRUG

intratumoral injections of 9 MIU/day on days 1, 4, 8, 11, 15, 18, 22 and 25. The administered dose will be distributed between all injectable soft-tissue metastases

Also known as: Proleukin®

Ipilimumab

Ipilimumab DRUG

IV infusion, 3 mg/kg, day 2, 23, 44, 65

Also known as: Proleukin

Ipilimumab

Eligibility Criteria

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

You may qualify if:

• Willing and able to give written informed consent;
• Histological diagnosis of malignant melanoma;
• Stage IV melanoma;
• At least one injectable lesions \> 5 mm (longest diameter) or at least 5 injectable lesions \< 5 mm.
• Measurable disease. Note: lesions, which are designated for direct IL -2 injections, must not be considered in the evaluation of measurability;
• Men and women, at least 18 years of age;
• Patient must have demonstrated 1 of the following in response to at least 1 cycle of 1 or more systemic regimens:
• relapse following an objective response (PR/CR);
• failed to demonstrate an objective response (PR/CR); or
• inability to tolerate treatment due to unacceptable toxicity
• At least 4 weeks since treatment (chemotherapy, biochemotherapy, surgery, radiation, immunotherapy, etc.) for melanoma and recovered from any clinically significant toxicity experienced during treatment;
• Life expectancy ≥3 months;
• ECOG performance status of 0 or 1;
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab;
• No known active or chronic infection with HIV, Hepatitis B, or Hepatitis C

You may not qualify if:

• Any other prior malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix;
• Ocular melanoma; mucosal melanoma
• Either untreated or symptomatic central nervous system (CNS) metastases (patients with brain metastases who are identified at screening may be rescreened after the lesion(s) have been appropriately treated);
• Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). Patients with vitiligo may be included.
• 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.
• Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
• A history of prior systemic treatment with ipilimumab, CD137 agonist, CTLA 4 inhibitor, CTLA-4 agonist or IL-2 in stage IV melanoma.
• Concomitant or less than 4 weeks off therapy with any of the following: interferon; other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; chronic use of systemic corticosteroids.
• Women of childbearing potential (WOCBP), defined in Section 5.3, who:
• are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or
• have a positive pregnancy test at baseline, or
• are pregnant or breastfeeding.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious) illness.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-2; aldesleukin; 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)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Benjamin Weide, Dr. med.

  University Hospital Tübingen

  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: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Benjamin Weide

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: February 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

DE (1)