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Trial record 6 of 34 for:    Lanreotide | Neuroendocrine Tumors

Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors (PLANET)

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ClinicalTrials.gov Identifier: NCT03043664
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : July 4, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Ipsen
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 6, 2017
Last Update Posted Date July 4, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Approximately every 12 weeks and/or re-staging through study completion (up to 2 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Approximately every 12 weeks and/or restaging through study completion (approximately 48 weeks) ]
Change History Complete list of historical versions of study NCT03043664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • Treatment-related adverse events [ Time Frame: Continuous, at minimum every 3 weeks until study completion (up to 2 years) ]
  • Progression free survival (PFS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause (whichever is first); assessed up to 48 weeks after the last subject enrolled ]
  • Overall survival (OS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of death from any cause; assessed up to 48 weeks after the last subject enrolled ]
  • ORR by Immune-Related Response Criteria (irRC) to pembrolizumab in combination with lanreotide depot in subjects with progressive, advanced or metastatic GEP-NETs. [ Time Frame: Approximately every 12 weeks and/or restaging until study completion (up to 2 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Treatment-related adverse events [ Time Frame: Continuous, at minimum every 3 weeks until study completion (approximately 48 weeks) ]
  • Progression free survival (PFS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause (whichever is first); assessed up to 48 weeks ]
  • Overall survival (OS) of pembrolizumab in combination with lanreotide depot in subjects with GEP-NETs. [ Time Frame: From date of randomization until the date of death from any cause; assessed up to 48 weeks ]
  • ORR by Immune-Related Response Criteria (irRC) to pembrolizumab in combination with lanreotide depot in subjects with progressive, advanced or metastatic GEP-NETs. [ Time Frame: Approximately every 12 weeks and/or restaging until study completion (approximately 48 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Official Title  ICMJE Phase Ib/II Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
Brief Summary

This study is for patients with non-resectable, recurrent, or metastatic well or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

The study will be conducted in two stages: 1) Safety Run-In and 2) Expanded Cohort.

  1. 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. Up to 6 patients at the Duke Cancer Institute will be accrued at the starting dose level. If one or less subject meets treatment-related discontinuation criteria (as specified in the protocol) during Cycle 1, then the study will proceed to the second stage, Expanded Cohort.
  2. Expanded Cohort: Patients will be treated with pembrolizumab 200mg IV every 3 weeks and lanreotide depot 90mg SQ every 3 weeks as determined by the Safety Run-In Cohort.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pembrolizumab 200mg IV every 3 weeks and lanreotide depot 90mg SQ every 3 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroenteropancreatic Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: Somatuline Depot
    Somatuline depot (Lanreotide depot) 90mg SQ every 3 weeks
  • Drug: Keytruda
    Keytruda (pembrolizumab) 200mg IV every 3 weeks
Study Arms  ICMJE Experimental: Arm 1
Keytruda (pembrolizumab) 200 mg intravenous (IV) every 3 weeks and Somatuline Depot (lanreotide depot) 90mg subcutaneous (SQ) every 3 weeks
Interventions:
  • Drug: Somatuline Depot
  • Drug: Keytruda
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to provide written informed consent for the trial.
  2. At least 18 years of age on day of signing informed consent.
  3. Non-resectable, recurrent, or metastatic well- or moderately-differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NETs) with disease progression within the last 12 months. (Patients who have received prior local therapy, including but not limited to embolization, chemoembolization, radiofrequency ablation, radiation therapy, are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of > 20% in the size. Prior local therapy must be completed at least 4 weeks prior to the baseline scan.)
  4. Prior somatostatin analogue therapy. (Patients should receive the first dose of study drug no sooner than 4 weeks from the last dose of somatostatin analogue.)
  5. At least one measurable lesion based on RECIST version 1.1.
  6. Agrees to provide available archived tumor tissue specimen. (Patients who do not have available archived tumor must agree to have core or excisional biopsy of a tumor lesion obtained up to 42 days prior to the first dose of study drug, if safely accessible.)
  7. ECOG performance status of 0 or 1 (refer to Appendix C).
  8. Adequate organ function defined as:

    • Absolute neutrophil count (ANC) ≥ 1,500 /mcL
    • Platelets ≥ 100,000 /mcL
    • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
    • Serum creatinine OR calculated creatinine clearance (CrCL) per institutional standard (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
    • Serum total bilirubin ≤ 1.5 X ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    • Albumin ≥ 2.5 mg/dL
  9. Negative serum pregnancy test within ≤ 7 days prior to the first dose of study drug, for women of childbearing potential only.
  10. Female subjects agree to use two birth control methods, be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug.
  11. Male subjects agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

  1. Tumor mitotic rate >20/10 hpf and/or Ki67 index >20% (if available).
  2. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
  3. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  4. Known history of active TB (Bacillus Tuberculosis).
  5. Hypersensitivity to pembrolizumab or lanreotide or any of their excipients.
  6. Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  7. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  8. Prior major surgery within 2 weeks prior to the first dose of study drug or who has not recovered adequately from the toxicity and/or complications from the intervention.
  9. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  10. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to the first dose of study drug. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  11. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  12. Known history of, or any evidence of active, non-infectious pneumonitis.
  13. Active infection requiring systemic therapy.
  14. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating physician.
  15. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  16. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of study drug.
  17. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  18. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  19. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  20. Live vaccine within 30 days of planned start of study drug regimen. Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  21. History of intolerance to somatostatin analogues.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Amara, MSW 919-668-1861 anthony.amara@duke.edu
Contact: Emily Bolch 919-668-1861 emily.bolch@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03043664
Other Study ID Numbers  ICMJE Pro00074917
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Ipsen
Investigators  ICMJE
Principal Investigator: Michael Morse, MD Duke University
PRS Account Duke University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP