Study of MK-8353 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Malignancies (MK-8353-013)

Inclusion Criteria:

- Part 1: Has a histologically- or cytologically-documented, locally-advanced or
metastatic solid malignancy and has received ≥1 and <6 prior line of cancer treatment
regimen(s).

- Part 2: Has a histologically-confirmed adenocarcinoma originating from the colon or
rectum (Stage 4 American Joint Committee on Cancer [AJCC] 7th edition) that is
microsatellite stable (i.e., non-MSI-H/dMMR). Appendiceal cancer is included AND Has
experienced disease progression or was intolerant to at least 1 and up to 5 systemic
chemotherapy regimen(s) for metastatic CRC that must have included fluroropyrimidines
and irinotecan or oxaliplatin, ± anti-vascular endothelial growth factor (VEGF) or
anti-epidermal growth factor receptor (EGFR)(if indicated by RAS mutational status).

- Provides an archival or newly obtained tumor tissue sample and blood samples for
biomarker analysis.

- Has ≥1 measurable lesion as defined by RECIST 1.1 on imaging studies.

- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale.

- Has adequate organ function

- Female participants of childbearing potential who are willing to use either 2 adequate
barrier methods, or to abstain from heterosexual activity throughout the study.

- Male participants of childbearing potential must agree to use an adequate method of
contraception.

Exclusion Criteria:

- Has disease that is suitable for local treatment administered with curative intent.

- Part 1: Has received prior therapy with cancer vaccines, or compounds targeting PD-1
(including Merck pembrolizumab [MK-3475]), programmed cell death ligand 1 (PD-L1),
PD-L2, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or Mitogen-activated
protein kinase (MAPK)/Extracellular signal-regulated Kinase (MEK).

- Part 2: Has received prior therapy with cancer vaccines, or compounds targeting PD-1
(including Merck pembrolizumab [MK-3475]), PD-L1, PD-L2, CTLA-4, lymphocyte-activation
gene 3 (LAG-3), CD-137, OX-40 (tumor necrosis factor receptor superfamily, member 4
[TNFRSF4], also known as CD134), cluster of differentiation 40 (CD-40),
glucocorticoid-induced TNFR-related protein (GITR), serine/threonine-protein kinase
B-Raf (BRAF), MEK or other molecules in the MAPK pathway.

- Is currently participating in or has participated in a study of an investigational
agent or using an investigational device within 4 weeks prior to the first dose of
study drug.

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in doses exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug.

- Has had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to study Day
1 or has not recovered (i.e. ≤ Grade 1 or at Baseline) from adverse events (AEs) due
to agents administered more than 4 weeks earlier.

- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 14 days prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at
baseline) from AEs due to a previously administered agent.

- Has received transfusion of blood products (including platelets or red blood cells) or
administration of colony stimulating factors within 4 weeks prior to study Day 1.

- Has a known additional malignancy that is progressing or requires active treatment.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.

- Has active autoimmune disease that has required systemic treatment in past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs).

- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.

- Has a history of interstitial lung disease.

- Has an active infection requiring systemic therapy.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study.

- Has a known history of Human Immunodeficiency Virus (HIV).

- Has known active Hepatitis B or Hepatitis C.

- Has received a live-virus vaccination within 30 days of planned treatment start.

- Has had an allogenic tissue/solid organ transplant.