Clinical Evaluation of Yervoy in Combination With Adoptive T Cell Transfer for Metastatic Melanoma Patients

NCT01988077 | Terminated Phase 2

• 1 other identifier: Ipilimumab TIL
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

A rationally designed combination of adoptive T cell therapy and ipilimumab could strongly increase the proportion of CR patients, as well as the durability of response, as compared to ipilimumab or TIL alone. The investigators hypothesize that the combination of those two important modalities could result in a durable (≥ 1 year) complete response rate of 30% in stage IV melanoma patients.

Conditions

A Combination of Adoptive T Cell Therapy and Ipilimumab Could Increase the Proportion of CR Patients, and Durability of Response

Outcome Measures

Primary Outcomes (1)

• Determine the response rate of the combination of ipilimumab with young TIL protocol and the CR rate of this combination according to modified RECIST 1.1.

  October 2017

Secondary Outcomes (1)

• • Evaluate the toxicity of this treatment regimen.

  Follow up for 1 year

Other Outcomes (2)

• Determine duration of response

  follow up for 1 year

• Determine overall survival

  follow up for 1 year

Study Arms (1)

Adoptive cell transfer combined with Ipilimumab

OTHER

Adoptive cell transfer combined with Ipilimumab

Biological: Adoptive cell transfer; Drug: Ipilimumab 5 MG/ML Injection [Yervoy]

Interventions

Adoptive cell transfer BIOLOGICAL

Adoptive cell transfer

Adoptive cell transfer combined with Ipilimumab

Ipilimumab 5 MG/ML Injection [Yervoy] DRUG

2 treatments of Ipilimumab before transfer of TIL and 2 treatments of Ipilimumab after TIL

Adoptive cell transfer combined with Ipilimumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, ≥ 18 years of age.
• Measurable metastatic melanoma (defined histologically) with at least one lesion that is resectable for TIL generation:
• Patients with asymptomatic brain metastases are allowed
• Previously treated or untreated unresectable stage III or stage IV melanoma
• Clinical performance status of ECOG 0 or 1.
• Laboratory:
• ANC ≥ than 1000 k/microL without support of filgrastim
• WBC \> 3000 k/microL
• Hemoglobin greater than 8.0 g/dL
• Platelet count greater than 100,000 K/microL
• Seronegative for HIV, HBV, HCV
• Serum ALT/AST less than three times the upper limit of normal.
• Serum creatinine less than or equal to 1.6 mg/dL.
• Total bilirubin less than or equal to 2 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3 mg/dl.
• An interval of at least 28 days since last oncological treatment to the first ipilimumab course. 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 systems due to brain metastases is decreased to the lowest fixed dose possible does not require 28-day waiting period.

You may not qualify if:

• 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).
• Active concurrent malignant disease, or disease-free for less than 5 years (exception: adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix)
• Patients receiving 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 exception of amantadine and flumadine, will not be eligible for ipilimumab treatment.
• 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.
• Active systemic infections, coagulation disorders or other active major medical illnesses:
• Cardiovascular:
• History of coronary revascularization or ischemic symptoms
• Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
• Left ventricular EF of 45% or less.
• Respiratory:
• Documented FEV1 less than or equal to 70% tested in patients with symptoms of respiratory dysfunction
• Immune system
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS)
• Hepatitis B and C infection, regardless of the control on antiviral therapy
• Opportunistic infections

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba. Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Interventions

Adoptive Transfer; Ipilimumab; Injections

Intervention Hierarchy (Ancestors)

Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy

Study Officials

• Jacob Schachter, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head - Ella Institute for Melanoma

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: May 20, 2016
• Study Completion: October 25, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

IL (1)