Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant

Part of paid clinical trials in New York, New York.

Sponsor
Ludwig Institute for Cancer Research
Study ID
NCT02716805
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Tremelimumab was administered as an intravenous (IV) infusion over 60 ± 5 minutes at a fixed dose of 75 mg, regardless of weight.
  • Durvalumab — DRUG
    Durvalumab was administered as an IV infusion over 60 ± 5 minutes at a fixed dose of 1500 mg for subjects weighing \> 30 kg. If a subject's body weight dropped to ≤ 30 kg on study, the subject was dosed at 600 mg for as long as the body weight remained ≤ 30 kg. When applicable, the durvalumab infusion was to start at least 60 minutes after the end of the tremelimumab infusion.
  • Prevnar-13 — BIOLOGICAL
    Prevnar-13 was administered as an intramuscular injection. The Prevnar-13 dose and the tremelimumab dose were to be separated by a minimum of 48 hours.
  • Melphalan — DRUG
    Melphalan was administered as an IV infusion according to institutional standard of care and local prescribing information.

Study Details

This was a Phase 1, open-label, multicenter, study of checkpoint inhibitor therapy (tremelimumab ± durvalumab) prior to and following autologous stem cell transplant (ASCT) and high-dose melphalan in subjects with multiple myeloma who were at a high risk for relapse, were eligible for ASCT, and had available cryopreserved stem cells. Primary study objectives were to determine the safety and tolerability of study treatment. Further objectives were to evaluate the clinical efficacy and biologic activity of the regimen.

Key Dates

Start date
Dec 13, 2016
Status verified
Oct 2022
Primary completion
Feb 16, 2018
Completion
Feb 16, 2018

Study Design

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

Arms

  • Experimental: Cohort 1
    Subjects received Prevnar-13 on Day -33 ± 2 days, tremelimumab (75 mg) on Day -31, leukopheresis on \~Day -10, melphalan (200 mg/m\^2) on Day -2, ASCT on Day 0, and reinfusion of PBLs and tremelimumab (75 mg) on Day 3. "Late" post-ASCT treatment comprised Prevnar-13 on Days 30 and 60, tremelimumab (75 mg) on Day 100 ± 10 days and Day 128 (Cycles 1 and 2), followed by up to 6 cycles of durvalumab (1500 mg) on Day 1 of Cycles 3 through 8.
  • Experimental: Cohort 2
    Subjects were to receive Prevnar-13 on Day -33 ± 2 days, tremelimumab (75 mg) on Day -31, leukopheresis on \~Day -10, melphalan (200 mg/m\^2) on Day -2, ASCT on Day 0, and reinfusion of PBLs and tremelimumab (75 mg) on Day 3. "Early" post-ASCT treatment comprised Prevnar-13 on Days 30 and 60, tremelimumab (75 mg) on Days 30 through 40 and Day 100 ± 10 days (Cycles 1 and 2), followed by up to 6 cycles of durvalumab (1500 mg) on Day 1 of Cycles 3 through 8.
  • Experimental: Cohort 3
    Subjects were to receive Prevnar-13 on Day -33 ± 2 days, tremelimumab (75 mg) + durvalumab (1500 mg) on Day -31, leukopheresis on \~Day -10, melphalan (200 mg/m\^2) on Day -2, ASCT on Day 0, and reinfusion of PBLs and tremelimumab (75 mg) on Day 3. "Late" post-ASCT treatment comprised Prevnar-13 on Days 30 and 60, tremelimumab (75 mg) + durvalumab (1500 mg) on Day 100 ± 10 days and Day 128 (Cycles 1 and 2), followed by up to 6 cycles of durvalumab (1500 mg) on Day 1 of Cycles 3 through 8.
  • Experimental: Cohort 4
    Subjects were to receive Prevnar-13 on Day -33 ± 2 days, tremelimumab (75 mg) + durvalumab (1500 mg) on Day -31, leukopheresis on \~Day -10, melphalan (200 mg/m\^2) on Day -2, ASCT on Day 0, and reinfusion of PBLs and tremelimumab (75 mg) on Day 3. "Early" post-ASCT treatment comprised Prevnar-13 on Days 30 and 60, tremelimumab (75 mg) + durvalumab (1500 mg) on Days 30 through 40 and Day 100 ± 10 days (Cycles 1 and 2), followed by up to 6 cycles of durvalumab (1500 mg) on Day 1 of Cycles 3 through 8.

Primary Outcome Measure

Number of Subjects With Treatment-emergent Adverse Events [ Time Frame: up to 14 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research FacilityNew YorkNew York10029-
Research FacilityNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Research Facility· New York, NY

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