Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma

Part of paid clinical trials in Stanford, California.

Sponsor
Ludwig Institute for Cancer Research
Study ID
NCT02659540
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab was administered as an intravenous (IV) infusion over approximately 30 or 90 minutes, with dosing calculated using body weight.
  • Ipilimumab — DRUG
    Ipilimumab was administered as an IV infusion over approximately 30 or 90 minutes, with dosing calculated using body weight. The ipilimumab infusion was initiated approximately 30 minutes after the end of the nivolumab infusion on applicable dosing days.
  • Radiotherapy — RADIATION
    RT was delivered in accordance with cohort assignment and institutional practices.

Study Details

This is an ongoing, Phase 1, open-label, multicenter, pilot study of the checkpoint antibodies ipilimumab and nivolumab in combination with radiotherapy (RT) in 18 subjects with unresectable Stage IV melanoma. The primary study objective is to evaluate the safety of study treatment. Secondary objectives are to evaluate objective response rate (ORR) and disease control rate (DCR) at Weeks 12 and 18, duration of response, progression-free survival (PFS), and overall survival (OS).

Key Dates

Start date
Oct 13, 2016
Status verified
Oct 2022
Primary completion
May 9, 2019
Completion
Jul 27, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (Conventional RT)
    Subjects received concurrent ipilimumab (3 mg/kg) and nivolumab (1 mg/kg) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg every 2 weeks or 480 mg every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
  • Experimental: Cohort B (Hypofractionated RT)
    Subjects received concurrent ipilimumab (3 mg/kg) and nivolumab (1 mg/kg) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg every 2 weeks or 480 mg every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.

Primary Outcome Measure

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 25 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteStanfordCalifornia94304-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Stanford, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Stanford Cancer Institute· Stanford, CAMemorial Sloan Kettering Cancer Center· New York, NY

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