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Trial record 1 of 11 for:    JNJ-63723283
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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT02908906
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2 and to determine one or more additional RP2Ds (Part 3 and Part 4).

Condition or disease Intervention/treatment Phase
Neoplasms Drug: JNJ-63723283 Phase 1 Phase 2

Detailed Description:
This is a First in Human (FIH), open-label (all people involved know the identity of the intervention), multicenter (more than 1 study site) study in participants with advanced cancers to establish the recommended Phase 2 dose (RP2D[s]) with IV administration for JNJ-63723283 in Part 1, to evaluate the safety and efficacy of the IV RP2D(s) in Part 2 and to determine one or more additional RP2Ds in Parts 3 and 4. Participant participation will include a Screening Phase (28 Days) during which participant eligibility will be reviewed prior to administration of the first dose of JNJ-63723283; a Treatment Phase that will start at the first dose and continue until treatment is discontinued; and a Survival Follow-up Phase (applicable for Part 1 and 2) starting upon completion of the End-of-Treatment Visit and ends when the participant completes or withdraws from the study. The end of the study is defined as last study assessment for the last participant on study or if the sponsor terminates the study, whichever comes first. Participants safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancers
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : January 12, 2022
Estimated Study Completion Date : January 21, 2022

Arm Intervention/treatment
Experimental: JNJ-63723283
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), IV every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous [SC] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4 to evaluate additional doses.
Drug: JNJ-63723283
JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Other Name: Cetrelimab




Primary Outcome Measures :
  1. Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT) [ Time Frame: Approximate 2.5 years ]
    Frequency and severity of dose-limiting toxicity will be reported.

  2. Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors [ Time Frame: Approximate 2.5 years ]
    Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

  3. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau]) [ Time Frame: Up to 2 years and 5 months ]
    AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: Approximate 2.5 years ]
    An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

  2. Maximum Observed Serum Concentration (Cmax) [ Time Frame: Approximate 2.5 years ]
    The Cmax is the maximum observed serum concentration.

  3. Parts 1 and 2: Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2]) [ Time Frame: Approximate 2.5 years ]
    AUC (t1-t2) is defined as the area under the serum concentration versus time curve between time t1 and t2.

  4. Parts 1, 2 and 3: Elimination Half-Life (t1/2) [ Time Frame: Approximate 2.5 years ]
    The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration.

  5. Parts 1 and 2: Total Systemic Clearance of (CL) [ Time Frame: Approximate 2.5 years ]
    Total systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.

  6. Parts 1 and 2: Volume of Distribution at Steady-State (Vss) [ Time Frame: Approximate 2.5 years ]
    The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of JNJ-63723283 at steady state.

  7. Parts 1, 2 and 4: Accumulation Ratio (R) [ Time Frame: Approximate 2.5 years ]
    The R is obtained by dividing AUC at two different time points.

  8. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t]) [ Time Frame: Up to 2 years and 5 months ]
    AUC (0-t) is defined as area under the serum concentration versus time curve between time zero and time t.

  9. Parts 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) [ Time Frame: Up to 2 years and 5 months ]
    AUC (0-infinity) is defined as area under the serum concentration versus time curve from time zero to infinity.

  10. Parts 3 and 4: Concentration just Prior to the Beginning of at the end of a Dosing Interval (Ctrough) [ Time Frame: Up to 2 years and 5 months ]
    Ctrough is defined as the concentration just prior to the beginning of at the end of a dosing interval.

  11. Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations [ Time Frame: Approximate 2.5 years ]
    Serum samples will be analyzed for antibodies to JNJ-63723283. The titer of the confirmed positive samples will be reported.

  12. Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC) [ Time Frame: Approximate 2.5 years ]
    ORR is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on irRC criteria.

  13. Duration of Response (DOR) per RECIST v1.1 [ Time Frame: Approximate 2.5 years ]
    For Participants who achieve CR or PR, DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

  14. Duration of Response (DOR) per irRC [ Time Frame: Approximate 2.5 years ]
    For Participants who achieve CR or PR (defined by irRC), DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

  15. Clinical Benefit Rate (CBR) per RECIST v1.1 [ Time Frame: Approximate 2.5 years ]
    The CBR is defined as the percentage of participants who achieve CR, PR or stable disease (SD; greater than or equal to [>=] 24 weeks from the 1st study drug) based on RECIST v1.1 criteria.

  16. Clinical Benefit Rate per irRC [ Time Frame: Approximate 2.5 years ]
    The CBR is defined as the percentage of participants who achieve CR, PR or SD (>= 24 weeks from the 1st study drug) based on irRC criteria.

  17. Progression-free Survival (PFS) per RECIST v1.1 [ Time Frame: Approximate 2.5 years ]
    The time from first dose of JNJ-63723283 to progressive disease as defined by RECIST v 1.1 or death due to any cause.

  18. Progression-free Survival (PFS) per irRC [ Time Frame: Approximate 2.5 years ]
    The time from first dose of JNJ-63723283 to progressive disease as defined by irRC or death due to any cause.

  19. Overall Survival (OS) [ Time Frame: Approximate 2.5 years ]
    The time from first dose of JNJ-63723283 to death due to any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
  • Has thyroid function laboratory values within normal range
  • Women of childbearing potential must have a negative serum pregnancy test
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy

Exclusion Criteria:

  • Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
  • Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
  • Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
  • Grade 3 or higher toxicity effects from previous treatment with immunotherapy
  • A woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

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): NCT02908906


Contacts
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02908906    
Other Study ID Numbers: CR108223
2016-002017-22 ( EudraCT Number )
63723283LUC1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Device Product: No