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

NCT04525638 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-02

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

177Lu-Dotatate

7.4 GBq 177Lu-DOTATATE intravenously as a 4-hours infusion

DRUG

Nivolumab

240 mg flat dose of nivolumab intravenously as a 30-minutes infusion

Sponsors & Collaborators

  • Syntax for Science, S.L

    collaborator INDUSTRY

  • Fundación de investigación HM

    lead OTHER

Principal Investigators

  • Antonio Cubillo, MD · Director

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04525638 on ClinicalTrials.gov