A Clinical Study to Assess the Combination of Two Drugs (177Lu-DOTATATE and Nivolumab) in Neuroendocrine Tumours

Sponsor
Fundación de investigación HM
Study ID
NCT04525638
Phase
PHASE2
Status
Unknown

Conditions

  • Neuroendocrine Carcinomas (NEC)
  • Neuroendocrine Tumours (NET)

Eligibility Criteria

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

Interventions

  • 177Lu-Dotatate — DRUG
    7.4 GBq 177Lu-DOTATATE intravenously as a 4-hours infusion
  • Nivolumab — DRUG
    240 mg flat dose of nivolumab intravenously as a 30-minutes infusion

Study Details

This is a prospective, multi-centre, open-label, single-arm, stratified, exploratory, Phase 2 study evaluating the efficacy and safety of 177Lu-DOTATATE in combination with nivolumab in adult patients with Grade 3 neuroendocrine tumours (NET) or neuroendocrine carcinomas (NEC).

Key Dates

Start date
Jun 29, 2020
Status verified
Jul 2022
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-DOTATATE + Nivolumab
    Patients will receive 240 mg flat dose of nivolumab intravenously as a 30-minutes infusion and 7.4 GBq 177Lu-DOTATATE intravenously as a 4-hours infusion

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Week 15 (+/-1) of treatment ]

Central Contacts

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