Overview

Phase II Randomized Trial of Ipilimumab Versus Ipilimumab and Radiotherapy in Metastatic Melanoma

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
An attractive area of research regards immune manipulations to recover some of the patient's immune response to his/her tumor, a strategy that has the advantages of being both natural and potentially long-lasting.[1] We propose to combine immunotherapy with radiotherapy directed to a metastatic site, to create a "hub" for in vivo immunization to the tumor, to enable "tumor rejection" at the other metastatic sites. This "in vivo immunization" is explored as a viable alternative to an individualized vaccine approach. Preclinical data generated by us and others support a "proof of principle" clinical trial that may open the field to an alternative use of radiotherapy in a novel partnership with cancer immunotherapy.[2]
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Antibodies, Monoclonal
Ipilimumab
Criteria
Inclusion Criteria:

- Ability to understand and the willingness to sign a written informed consent document;

- Histologic diagnosis of locally unresectable, metastatic melanoma.

- Any BRAF status is permitted

- Any prior therapy is permitted except prior therapy with ipilimumab.

- Patients must have at least 2 distinct measurable metastatic sites, with one of at
least 1 cm or larger in its largest diameter and may have additional non-measurable
but established metastatic lesions (i.e. bone metastases).

- Patients must have adequate organ and marrow function as defined by initial laboratory
tests:

- WBC 2000/uL

- ANC 1000/uL

- Platelets 50 x 103/uL

- Hemoglobin 8 g/dL

- Creatinine 3.0 x ULN

- AST/ALT 2.5 x ULN for patients without liver metastasis

- Bilirubin 3.0 x ULN, (except patients with Gilbert's Syndrome, who must have a
total bilirubin less than 3.0 mg/dL;

- Performance status ECOG 0-1 or Karnofsky > 50%;

- Men and women, ages > 18 year old of age;

- Life expectancy > 3 months

- Stable brain metastases for at least 4 weeks and not steroid dependent;

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 8 weeks after the
study.

Exclusion Criteria:

- Patients having no lesions outside the field of radiation thus nullifying the ability
to measure an abscopal effect;

- Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded
from this study as are patients with a history of symptomatic disease (e.g.,
rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus
Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis;

- Any underlying medical or psychiatric condition, which in the opinion of the
Investigator, will make the administration of study drug 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
one month prior to or after any dose of ipilimumab);

- Concomitant therapy with any of the following: IL-2, interferon or other non-study
immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other
investigation therapies; or chronic use of systemic corticosteroids;

- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for at least 8 weeks after cessation of study drug, or
have a positive pregnancy test at baseline, or are pregnant or breastfeeding;

- Persons of reproductive potential must agree to use and utilize an adequate method of
contraception throughout treatment and for at least 8 weeks after study drug is
stopped;

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness.