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Hormone Therapy

Arm 1 for Neuroendocrine Tumors (PLANET Trial)

Phase 1 & 2
Waitlist Available
Led By Michael Morse, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to provide written informed consent for the trial.
At least 18 years of age on day of signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately every 12 weeks until study completion (up to 2 years)
Awards & highlights

PLANET Trial Summary

This trial is for patients with non-resectable, recurrent, or metastatic well or moderately differentiated gastroenteropancreatic neuroendocrine tumors. The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort. In the Safety Run-In, the first stage will include a safety run-in of 6 patients treated with pembrolizumab 200 mg intravenous (IV) every 3 weeks and lanreotide depot 90mg subcutaneous (SQ) every 3 weeks. If one or less subject meets treatment-related discontinuation criteria during Cycle 1, then the study

Eligible Conditions
  • Neuroendocrine Tumors

PLANET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PLANET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately every 12 weeks until study completion (up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately every 12 weeks until study completion (up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Secondary outcome measures
Months of Overall Survival (OS)
Months of Progression-free Survival (PFS)
Number of Participants Experiencing Treatment-related AEs Leading to Drug Discontinuations During the First 12 Weeks of Treatment
+1 more

PLANET Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanreotide
2009
Completed Phase 3
~600
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

IpsenIndustry Sponsor
344 Previous Clinical Trials
73,017 Total Patients Enrolled
34 Trials studying Neuroendocrine Tumors
2,982 Patients Enrolled for Neuroendocrine Tumors
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,431 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,863 Previous Clinical Trials
5,049,868 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
2,178 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025