Recruiting
Phase 2

Ipilimumab & SART

Sponsor:

Wolfram Samlowski

Code:

NCT01565837

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ipilimumab

Stereotactic Ablative Radiosurgery (SART)

Study Details

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

Study ID

NCT01565837

Start date

Aug, 2012

Status verified date

Jan, 2016

Completion date

Nov, 2017

Anticipated

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Autoimmune disease (vitiligo is not a basis for exclusion).
  • History of clinically active diverticulitis (diverticulosis is not exclusion criterion per se).
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ipilimumab + SART

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

Interventions

Ipilimumab

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.

Stereotactic Ablative Radiosurgery (SART)

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).

Primary outcome measure

  • Safety and tolerability of concurrent ipilimumab and SART - Acute Toxicity [ Time Frame: Week 9 ]
  • Safety and tolerability of concurrent ipilimumab and SART - Subacute Toxicity [ Time Frame: Week 15 ]

Central Contacts and Locations

Central contacts

Wolfram Samlowski, MD

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

Khin Win

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

Locations

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89148

Contacts

Khin Win

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

More Information

Sponsor

Wolfram Samlowski

Last update posted

Feb 1, 2016

Last verified

Jan, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wolfram Samlowski on 2016-02-01.