A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Ravi Amaravadi, MD
Study ID
NCT04464759
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab
  • Hydroxychloroquine — DRUG
    Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab
  • Ipilimumab — DRUG
    Combination of nivolumab, hydroxychloroquine and ipilimumab

Study Details

This study will evaluate the safety, tolerability and efficacy (objective response rate) of using hydroxychloroquine (HCQ) in combination with nivolumab and ipilimumab or with nivolumab alone in subjects with advanced/metastatic melanoma.

Key Dates

Start date
Oct 21, 2020
Status verified
Jul 2025
Primary completion
Jan 6, 2027
Completion
Jan 6, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Nivolumab and Hydroxychloroquine (HCQ)
    Dose escalation: Dose Level 1: HCQ 400 mg orally every 12 hours and nivolumab 480 mg IV every 4 weeks Dose Level 2: HCQ 600 mg orally every 12 hours and nivolumab 480 mg IV every 4 weeks Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.
  • Experimental: Phase 2: Nivolumab and Hydroxychloroquine (HCQ)
    HCQ 400-600 mg (maximum tolerated dose from Phase 1a) orally every 12 hours and nivolumab 480 mg IV every 4 weeks Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.
  • Experimental: Phase 1b: Nivolumab + Ipilimumab +Hydroxychloroquine (HCQ)
    HCQ 400-600 mg orally every 12 hours and nivolumab 3 mg/kg IV plus ipilimumab 1 mg/kg IV every 3 weeks x4 cycles Then 6 weeks after the last dose of ipilimumab/nivolumab begin maintenance nivolumab 480 mg IV every 4 weeks Continue protocol treatment for up to 24 months until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-mandated study removal.

Primary Outcome Measure

Phase 1: Maximum tolerated dose (MTD) - Number of Subjects with Dose-limiting Toxicities [ Time Frame: From first dose of protocol treatment to 16 to 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at University of PennsylvaniaPhiladelphiaPennsylvania19104
Lydia Giles, BSN, RN
[email protected]
215-662-6389

Find similar trials in Philadelphia, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Abramson Cancer Center at University of Pennsylvania· Philadelphia, PA

Related Studies