Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas

Conditions

• High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Given Intravenously (IV)
• Irinotecan — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV

Study Details

This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary poorly differentiated neuroendocrine carcinoma

Key Dates

Start date

Jun 20, 2017

Status verified

Dec 2022

Primary completion

Oct 31, 2021

Completion

Oct 31, 2021

Study Design

Enrollment

36 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Pembrolizumab only
  Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
• Experimental: Part B: Pembrolizumab + Chemotherapy
  Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]

Locations (3)

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