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Adoptive cells transfer (TCR) with/without checkpoint inhibitor (anti PD-1)
[*similar* concept that TCR trial at NIH (NCT03412877)]
NeoTCR-P1 adoptive cell therapy
nivolumab (Opdivo, anti PD-1)

NeoTCR P1 is an autologous adoptive T cell therapy (ACT) for patients with solid cancer.
“Upon reinfusion of a defined dose into the patient, NeoTCR-P1 cells are anticipated to traffic to tissues harboring tumor cells presenting the neoE peptide in the context of the autologous cognate HLA receptor. Recognition of the cognate neoE-HLA complexes will trigger Tcell proliferation and secretion of effector molecules from the engineered Tcells.”

Key inclusion/exclusion criteria.
– Disease has progressed after at least one available standard therapy or no additional curative therapies are available
– Measurable disease
– Prior chimeric antigen receptor therapy or other genetically modified T cell therapy (that means that prior checkpoint inhibitor is allowed)

Inclusion Criteria

Inclusion Criteria:

Histologically or cytologically documented incurable or metastatic solid tumors of the following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+), or prostate cancer.
Disease has progressed after at least one available standard therapy or no additional curative therapies are available.
Measurable disease per RECIST v1.1
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Adequate hematologic and end organ function determined within 30 days prior to enrollment.
Disease-specific criteria related to the specific tumor type are required.

Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.

Exclusion Criteria

Exclusion Criteria:

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and/or inherited liver disease
Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Uncontrolled or symptomatic hypercalcemia
Pregnancy, lactation, or breastfeeding
Prior allogeneic stem cell transplant or solid organ transplant
Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
Active HIV, Hepatitis B, or Hepatitis C infection
Active tuberculosis
Severe infection within 2 weeks prior to enrollment
Major surgical procedure within 4 weeks prior to enrollment or anticipation of need for a major surgical procedure during the study.

Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.