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No longer recruiting (closed or complete)Last updated: 2 February 2024

This phase I/II trial is evaluating a new type of immunotherapy, known as a neoantigen cancer vaccine, in combination with two established immunotherapies, as a treatment for several different types of cancerAn International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Conditions

This trial is treating people with non-small cell lung cancer, colorectal cancer, gastro-oesophageal cancer or urothelial cancer

Eligibility

Inclusion

  • Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
  • Patients with the indicated advanced or metastatic solid tumor as follows:

    1. NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
    2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    4. CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
  • 18 years of age or older
  • ECOG Performance Status 0 or 1
  • Lesion amenable to biopsy
  • Measurable disease according to RECIST v1.1
  • Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

Exclusion

  • Tumors with genetic characteristics as follows:

    1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
    2. For CRC and GEA, patients with known MSI-high disease based on institutional standard
    3. For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
  • Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
  • Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws

Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Gritstone Oncology, Bristol-Myers Squibb (BMS)

Scientific Title

An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

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