Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: 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

Summary: The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1 and 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), and gastric/esophageal cancer in Part 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]) for JNJ-63723283 in Part 1 and to evaluate the safety and efficacy of the RP2D(s) in Part 2. Subject 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 starting upon completion of the End-of-Treatment Visit and ends when the participant completes or withdrawals 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.

Eligibility: 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

Relevance to patient case: not relevant