Phase
Condition
Head And Neck Cancer
Ovarian Cancer
Carcinoma
Treatment
TJ004309
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopiantube, or primary peritoneal cancer subjects with any high-grade serous component,progressed on or after platinum-containing therapy and not eligible for furtherplatinum containing treatment (platinum-resistant, platinum-refractory disease definedby progression of disease on a platinum-containing regimen or recurrence of diseasewithin 180 days of receiving the last dose of platinum-based treatment).
- Cohort 2: Patients with selected tumor types that have relapsed or progressed after 2lines of therapy or who are ineligible for other standard of care (SOC) therapies:
- Histologically or cytologically confirmed metastatic NSCLC
- Histologically or cytologically confirmed recurrent or metastatic HNSCC (oralcavity, oropharynx, hypopharynx, or larynx)
- Histologically or cytologically confirmed metastatic or non-resectable advancedmetastatic gastric or gastroesophageal adenocarcinoma
- Histologically or cytologically confirmed unresectable, locally advanced ormetastatic TNBC (confirmed HER2-negative, estrogen receptor-negative andprogesterone receptor-negative)
- Histologically confirmed ovarian cancer of all high-grade epithelial types whoare IO treatment naïve and have progressed after 3 months on or afterplatinum-containing therapy
- PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and CombinedProportion Score (CPS) ≥ 1% for all other tumor types
- A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1therapy
- Patients should have no more than 5 prior lines of therapies
- Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies andpaired treatment fresh tumor biopsies will be collected from at least 5 patients.Biopsy must be excisional, incisional, or core.
Exclusion
Exclusion Criteria:
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or withan agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factorreceptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptorsuperfamily member 9 (TNFRSF9)]) (only applies to ovarian cancer patients in Cohorts 1and 2)
- Disease progression within 6 months of starting anti-PD-1 and anti-PD-L1 inhibitors
- Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcoholsteatohepatitis, alcohol or drug-related, autoimmune) serology at screening orcirrhosis
- Active autoimmune disease requiring systemic treatment within the past 12 months
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD
- Brain involvement with cancer, spinal cord compression, carcinomatous meningitis, ornew evidence of brain or leptomeningeal disease; unless the lesion(s) have beenradiated or resected, are considered fully treated and inactive, are asymptomatic, andno steroids have been administered for CNS disease over the 7 days prior to studytreatment
- Angina, myocardial infarction (MI), symptomatic congestive heart failure,cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonaryembolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary arterybypass grafting (CABG) within 6 months prior to study treatment
- Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL withan undetectable viral load
Study Design
Study Description
Connect with a study center
Arizona Oncology Associates
Tucson, Arizona 85711
United StatesSite Not Available
Innovative Clinical Research Institute
Whittier, California 90603
United StatesSite Not Available
Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
United StatesSite Not Available
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
United StatesSite Not Available
Affiliated Oncologists
Chicago Ridge, Illinois 60415
United StatesSite Not Available
Women's Cancer Care
Covington, Louisiana 70433
United StatesSite Not Available
Maryland Oncology Hematology
Rockville, Maryland 20850
United StatesSite Not Available
New York Oncology Hematology
Albany, New York 12206
United StatesSite Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United StatesSite Not Available
Duke Cancer Center
Durham, North Carolina 27710
United StatesSite Not Available
Tri County Hematology and Oncology Associates
Massillon, Ohio 44646
United StatesSite Not Available
Texas Oncology - Arlington North
Arlington, Texas 76012
United StatesSite Not Available
Texas Oncology - Austin Central
Austin, Texas 78731
United StatesSite Not Available
Texas Oncology - Bedford
Bedford, Texas 76022
United StatesSite Not Available
Texas Oncology - Forth Worth Cancer Center
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas 77380
United StatesSite Not Available
Texas Oncology - Longview Cancer Center
Tyler, Texas 75601
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Northwest Cancer Specialists
Vancouver, Washington 98684
United StatesSite Not Available

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