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Trial record 10 of 14 for:    iab22M2C OR crefmirlimab

CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05289193
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.

Condition or disease Intervention/treatment Phase
Melanoma Melanoma Stage III Diagnostic Test: PET Scan Drug: Nivolumab Drug: Ipilimumab Procedure: Surgical Resection of Melanoma Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)
Actual Study Start Date : March 11, 2022
Estimated Primary Completion Date : March 11, 2024
Estimated Study Completion Date : March 11, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Participants with Stage III Melanoma
All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.
Diagnostic Test: PET Scan

Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab

1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.

Other Name: 89Zr-Df-Crefmirlimab

Drug: Nivolumab

Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab

1mg/kg + ipilimumab 3mg/kg.


Drug: Ipilimumab

Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab

1mg/kg + ipilimumab 3mg/kg.


Procedure: Surgical Resection of Melanoma

Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab

1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.





Primary Outcome Measures :
  1. Major pathologic responses/MPR [ Time Frame: up to 2 years ]
    Participants' disease will be assessed for MPR as per previously established criteria for neoadjuvant trials (near complete response ≤10% viable; complete response 0% viable). Pathologic response (≤50% viable) will also be estimated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
  • Adults at least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Cytologically or histologically confirmed stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.

Notes:

  • In-transit melanoma is acceptable.
  • Patients can enroll regardless of their BRAF mutational status

    • 1cm of tumor needs to be visible on standard imaging (i.e. FDG PET or CT scan)
    • Screening laboratory values must meet the following criteria:
  • WBC ≥ 2.0x109/L
  • Neutrophils ≥ 1.5x109/L
  • Platelets ≥ 100 x109/L
  • Hemoglobin ≥ 5.5 mmol/L
  • Creatinine ≤ 1.5x ULN
  • AST ≤ 1.5 x ULN and ALT ≤ 1.5 x ULN
  • Bilirubin ≤1.5 X ULN

    • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of study treatment (ipilimumab/nivolumab)
    • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab + nivolumab
    • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of study treatment (ipilimumab/nivolumab)

Note: Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically sterile as well as azoospermic men do not require contraception

Exclusion Criteria:

  • Subjects with any active autoimmune disease (current symptoms or requirement for immunosuppression at the time of study start).
  • Positive active hepatitis B viral infection (+viral load by PCR)
  • Prior immunotherapy targeting CTLA-4 and/or PD-1/PD-L1 for any disease.
  • Potentially unresectable melanoma.
  • History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • History of severe hypersensitivity reaction to any monoclonal antibody
  • Underlying medical conditions that, in the Investigator's opinion, will make the administration of treatment hazardous or obscure the interpretation of toxicity
  • Patients who have undergone splenectomy or have other splenic disorders. The normal spleen usually has CD8+ cell activity and serves as a positive control to enable proper imaging technique.
  • Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion
  • Pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05289193


Contacts
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Contact: Michael Postow, MD 646-888-4589 postowm@mskcc.org
Contact: Neeta Pandit-Taskar 2126393046 pandit-n@MSKCC.ORG

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Michael Postow, MD    646-888-4589      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michael Postow, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05289193    
Other Study ID Numbers: 21-456
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
CD8+ Cell Imaging
C-IT Neo Trial
stage III melanoma
89Zr-Df-Crefmirlimab
Memorial Sloan Kettering Cancer Center
21-456
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action