Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

This research study is a PhaseI/II clinical trial investing a combination of targeted
therapies as possible treatment for advanced solid cancers

FDA has not yet approved Poly-ICL as treatment for diseases in this study

Pembrolizumab, Nivolumab, Atezolizumab, and Durvalumab are now FDA approved for certain
patients with multiple cancer types.

The study is designed to evaluate the safety of intramuscular (IM) Polyinosinic-polycytidylic
acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®) in
combination with Anti-PD-1 or Anti-PD-L1 for treatment of study subjects with advanced solid
cancers.

Inclusion Criteria:

1. Histologically confirmed diagnosis of Solid Cancer, independent of PD-L1 tumor status.

2. Patients must be 18 years of age or older.

3. Unresectable disease. Patients with resectable disease but who refuse surgery may be
enrolled after a documented consultation with a surgeon.

4. Radiologically or visually measurable disease that is at least 10mm in longest
dimension, AND/OR with elevated disease specific serum markers that can be followed
for progression (eg CA-125, AFP, PSA, CA19-9 or CEA)

5. ECOG performance status of ≤ 2.

6. Acceptable hematologic, renal and liver function as follows:

A) Absolute neutrophil count > 1000/mm3 B) Platelets > 50,000/mm3, C) Creatinine ≤ 2.5
mg/dl, D) Total bilirubin ≤ 1.5 mg/dl, E) Transaminases ≤ 2 times above the upper
limits of the institutional normal. F) INR<2 if off of anticoagulation. Patients on
anticoagulation therapy with an INR>2 may be enrolled at the discretion of the
investigator if they have not had any episodes of severe hemorrhage..

7. Patients must be able to provide informed consent.

8. Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception. Contraception must be
continued for at least 2 months following the last dose of Poly-ICLC. Women of
childbearing potential must have a negative pregnancy test. While animal reproductive
studies have been negative, the simulated viral infection and anti-proliferative
activity of this experimental drug may theoretically affect the developing fetus or
nursing infant.

Exclusion Criteria:

1. Serious concurrent infection or medical illness, which would jeopardize the ability of
the patient to receive the treatment outlined in this protocol with reasonable safety

2. Persistent toxicity from recent therapy that has not sufficiently resolved in the
judgment of the study physician