This phase Ib trial is testing an investigational TG02 treatment in patients with locally recurrent rectal cancerA Non-Randomised Open-Label Phase Ib Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Recurrent Oncogenic RAS Exon 2 Mutant Rectal Cancer

Exclusion

• The patient has previously received an anticancer vaccine or immune checkpoint inhibitor, or participated in a trial involving the use of an anticancer vaccine or immune checkpoint inhibitor
• Patients where pre-surgery radiotherapy, chemotherapy or other anti-cancer therapy has not been completed ≥ 2 weeks prior to TG02-treatment
• The patients is receiving anti-cancer therapy for concurrent illness
• The patient has had a prior different malignancy within the last 3 years (excluding adequately treated basal cell or squamous cell carcinoma of the skin cancer, or localised low grade tumours considered cured and not requiring systemic therapy)

• The patient has uncontrolled or significant intercurrent or recent illness including:

  • auto-immune disorder or history of autoimmune disease requiring immunosuppressive treatment.
  • cardiac disorder such as uncontrolled cardiac failure, unstable angina or non-ST segment elevation myocardial infarction (NSTEMI) or myocardial infarction, uncontrolled arrhythmia less than 3 months before screening
  • stroke or thromboembolic event within 3 months of study commencement
  • active or uncontrolled severe infection
  • history of solid organ transplantation or any condition requiring chronic treatment with corticosteroids or other immunosuppressive agents
  • active coagulopathy/bleeding diathesis
  • cirrhosis, chronic active or untreated persistent hepatitis
  • history of adverse reactions to peptide vaccines
• The patient is pregnant or lactating.
• Has received an investigational drug within 4 weeks prior to study drug administration, or unless other has been agreed with the medical monitor
• Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma)
• Known history of positive tests for HIV/AIDS
• Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study
• For Part II - any contraindication to receiving pembrolizumab:

If using the 50 mg lyophilized powder; hypersensitivity to the active substance (pembrolizumab) or to any of the excipients; L-histidine, L-histidine hydrochloride monohydrate, Sucrose, Polysorbate 80.

If using the 100 mg concentrate; hypersensitivity to the active substance (pembrolizumab) or to any of the excipients; L-histidine, Sucrose, Polysorbate 80