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A Study of Amivantamab in People With Esophagogastric Cancer

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: NCT05117931
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to see whether the study drug, amivantamab, is an effective treatment for people with EGFR- or MET-amplified esophagogastric cancer. The researchers will also look at whether amivantamab is a safe treatment that causes few or mild side effects in participants.

Condition or disease Intervention/treatment Phase
Esophagogastric Cancer Drug: Amivantamab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm, phase II study of Amivantamab.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Amivantamab in EGFR or MET- Amplified Esophagogastric Cancer
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Amivantamab

Arm Intervention/treatment
Experimental: Amivantamab
Patients will receive amivantamab intravenously weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (patients <80kg) or 1400mg (patients ≥80kg). The initial dose will be administered over 2 days in split doses in order to mitigate the risk of infusion reactions. Therapy will continue for up to 2 years or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reason to discontinue treatment occurs-whichever comes first.
Drug: Amivantamab
Patients will receive amivantamab weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (<80kg) or 1400mg (>80kg). The first day of dosing is considered Cycle 1 Day 1. Each cycle is 28 days in duration. The initial dose will be administered over 2 days to prevent infusion reactions. For patients who weigh <80 kg, amivantamab 350mg IV will be given on Cycle 1 Day 1, and the remaining 700mg IV will be given on Cycle 1 Day 2. Patients will continue to receive amivantamab 1050mg IV once a week during Cycle 1 then biweekly (Days 1 and 15) of each subsequent Cycle. For patients who weigh ≥ 80 kg, 350mg IV amivantamab will be given on Cycle 1 Day 1 and 1050mg IV will be given on Cycle 1 Day 2. Patients will continue to receive amivantamab 1400mg IV once a week during Cycle 1 then biweekly (Days 1 and 15) of each subsequent Cycle.




Primary Outcome Measures :
  1. objective response rate [ Time Frame: 1 year ]
    ORR; defined as complete response (CR) or partial response (PR)) by RECIST 1.1 criteria



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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:

  • Subject or legally authorized representative is willing and able to provide written informed consent.
  • Patients with previously treated metastatic or unresectable histologically-confirmed esophagogastric cancer who have received at least 1 line of therapy.
  • EGFR or MET amplification by tissue-NGS with copy number >8 and/or ctDNA amplification by any FDA and CLIA-approved assay
  • No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer. (Note: if a patient previously received a EGFR inhibitor, but subsequently demonstrated a MET amplification, or previously received a MET inhibitor, but subsequently demonstrated an EGFR-amplification, inclusion is permitted).
  • Patients with HER2+ (IHC 3+ or IHC 2+/FISH+) tumors must have progressed on trastuzumab.
  • Measurable disease based on RECIST 1.1.
  • ≥ 18 years of age on day of signing informed consent.
  • Have an ECOG performance status of 0, 1, or 2.
  • Adequate organ function, defined as:

A. Hemoglobin ≥9 g/dL

B. ANC ≥1.0 x 10^9 /L

C. Platelets ≥75 x 10^9 /L

D. AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases)

E. Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits

F. Serum creatinine <1.5 x ULN or if available, calculated or measured creatinine clearance >50 mL/min/1.73 m^2

  • Women of childbearing potential and male patients with women of childbearing potential partners must be willing to use an adequate method of contraception

Exclusion Criteria:

  • Prior chemotherapy, targeted small molecule therapy, or biological therapy, within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (excluding alopecia).
  • If subject received major surgery, they must have recovered adequately prior to starting therapy.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Known active hepatitis B (e.g., HBsAg reactive or polymerase chain reaction detectable).

Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.

  • Known active hepatitis C (e.g., HCV RNA [qualitative] is detected).

Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.

  • Other clinically active or chronic liver disease.
  • Subject has uncontrolled inter-current illness, including but not limited to poorly controlled diabetes, ongoing or active infection (i.e., has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Subjects with medical conditions requiring chronic continuous oxygen therapy are excluded.
  • Pulmonary embolism (PE) and deep vein thrombosis (DVT), within 1 month of start of study drug.
  • Myocardial infarction, unstable angina, stroke, transient ischemic attach (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug.
  • Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of start of study drug.
  • Interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents that is unresolved or resolved within the last 3 months.
  • Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.
  • Is 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 6 months after the last dose of trial treatment.
  • Prisoners, or subjects who are compulsory detained.

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): NCT05117931


Contacts
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Contact: Steven Maron, MD 646-888-6780 marons@mskcc.org
Contact: Yelena Janjigian, MD 646-888-4186

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Steven Maron, MD    646-888-6780      
Memorial Sloan Kettering Monmouth (Limited protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Steven Maron, MD    646-888-6780      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Steven Maron, MD    646-888-6780      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Steven Maron, MD    646-888-6780      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Steven Maron, MD    646-888-6780      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Steven Maron, MD    646-888-6780      
Memorial Sloan Kettering Nassau (Limited protocol activities) Recruiting
Rockville Centre, New York, United States, 11553
Contact: Steven Maron, MD    646-888-6780      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Janssen Pharmaceuticals
Investigators
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Principal Investigator: Steven Maron, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05117931    
Other Study ID Numbers: 21-324
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
metastatic
unresectable
Amivantamab
EGFR or MET amplified
21-324