Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for Oligometastatic But Unresectable Melanoma

NCT01565837 | Unknown Phase 2 DMC

• 1 other identifier: BMS CA184-168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer sites (oligometastatic). Blood samples will be collected for research purposes. Planned studies include exploration of certain gene mutations and serum markers as predictors of response to ipilimumab treatment. Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately detected and isolated from the blood using novel laboratory techniques and if they are a prognostic/predictive marker for treatment response. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

Conditions

Melanoma

Keywords

Melanoma; Malignant Melanoma; Metastatic; Oligometastatic; Radiosurgery; Radiosurgery, Stereotactic; Stereotactic Radiosurgery; Ipilimumab; Yervoy; MDX-010; Circulating Tumor Cells

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of concurrent ipilimumab and SART - Acute Toxicity

  Week 9

• Safety and tolerability of concurrent ipilimumab and SART - Subacute Toxicity

  Week 15

Secondary Outcomes (4)

• 1-year disease control rates (CR+PR+SD) based on irRC and mWHO criteria

  2 year minimum follow up on study participants

• 2-year disease control rates (CR+PR+SD) based on irRC and mWHO criteria

  2 year minimum follow up on study participants

• 1-year overall survival

  2 year minimum follow up on study participants

• 2-year overall survival

  2 year minimum follow up on study participants

Study Arms (1)

Ipilimumab + SART

EXPERIMENTAL

Patients with oligometastatic but unresectable malignant melanoma will receive induction ipilimumab plus concurrent SART followed by maintenance ipilimumab.

Drug: Ipilimumab; Radiation: Stereotactic Ablative Radiosurgery (SART)

Interventions

Ipilimumab DRUG

Ipilimumab 10mg/kg administered intravenously over 90-minute period every 3 weeks for a total of four doses as tolerated. Maintenance ipilimumab (10 mg/kg intravenously every 3 months) will be administered beginning Week 24, as long as there is clinical benefit in the opinion of the investigator using immune related response criteria, and there are no novel or unexpected Grade 3 or 4 toxicities.

Also known as: Yervoy, MDX-010

Ipilimumab + SART

Stereotactic Ablative Radiosurgery (SART) RADIATION

Definitive radiotherapy will be administered to up to 1-5 lesions using SART techniques after initial dose of ipilimumab. Radiotherapy will be timed before start of 3rd cycle of ipilimumab treatment to maximize synergy (week 6).

Ipilimumab + SART

Eligibility Criteria

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

You may qualify if:

• Stage III or IV melanoma (AJCC 6th edition) with 5 or less metastatic sites that are not amenable to curative surgical resection, but can be adequately delineated for SART
• All sites of metastatic disease acceptable except brain-only and eye metastases, provided SART can be safely delivered to the site.
• Up to 2 prior systemic treatments for metastatic disease.
• Mucosal or ocular melanoma is allowed.
• Radiotherapy consultation and insurance preapproval for SART prior to enrollment.
• CT or MRI within 28 days of enrollment showing no evidence of brain metastases. Brain metastases allowed if stable by scans for ≥ 28 days following treatment.
• CT, PET/CT or MRI scan of chest, abdomen, pelvis (and soft tissue as indicated); bone scan (as indicated); and photographs of skin lesions (if applicable) within 28 days of enrollment.
• Hematology, liver function and renal function lab tests within required parameters.
• Recovered from all prior surgery and/or adjuvant treatment.
• No active or chronic infection with HIV, Hepatitis B or Hepatitis C.
• ECOG Performance Status 0 or 1.
• Men and women ≥ 18 years old.
• Men/Women of childbearing potential must use adequate contraception.

You may not qualify if:

• Untreated or uncontrolled brain metastases.
• Prior treatment with CTLA-4 agent, PD-1 or PD-1 ligand mAb or inhibitor for metastatic disease or as adjuvant therapy (or participation in blinded study).
• History of melanoma-associated retinopathy.
• History of other active malignancy within last 2 years, except adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of cervix, unless disease-free for 2 years.
• Serious uncontrolled medical disorder or active infection that would impede treatment.
• Underlying medical or psychiatric condition that would cause administration of ipilimumab to be hazardous, or would obscure interpretation of AEs.
• Any non-oncology vaccine therapy up to 1 month before or after any dose of ipilimumab.
• Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
• Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
• Pregnant or breastfeeding women.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.

Sponsors & Collaborators

• Wolfram Samlowski: lead
• Comprehensive Cancer Centers of Nevada: collaborator

Study Sites (1)

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Neoplastic Cells, Circulating

Interventions

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wolfram Samlowski, MD

  Comprehensive Cancer Centers of Nevada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfram Samlowski, MD

CONTACT

702-952-1251; wolf.samlowski@usoncology.com

Khin Win

CONTACT

702-419-5550; khin.win@usoncology.com

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: Physician, Comprehensive Cancer Centers of Nevada; Member, Developmental Therapeutics and Genitourinary Committee, US Oncology Research; Clinical Professor, University of Nevada, Reno

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 29, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

US (1)