Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Signed and dated informed consent(s) by the participant or legal representative before
any trial-related activities.
- Female over 18 years of age on day of signing informed consent(s).
- Histologically confirmed ovarian cancer (including fallopian tube and primary
peritoneal cancer) resistant to platinum (defined as progression of cancer within 183
days of the most recent dose of cisplatin or carboplatin) or refractory to platinum
(defined as progression of cancer within 30 days of the most recent dose of cisplatin
or carboplatin) ovarian cancer, which cannot be treated with curative intent with
available therapies. Note: Poly(ADP)-ribose polymerase (PARP) inhibitors should be
considered as indicated in clinical practice, prior to trial enrollment.
- At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local
virus injection (intratumoral and/or intraperitoneal).
- The disease burden must be evaluable, but does not need to fulfil RECIST 1.1.
- Have adequate organ function as defined in the following values below. Specimens must
be collected within 10 days prior to the start of study treatment.
a. Hematological laboratory values i. Absolute neutrophil count (ANC): ≥1500/µL ii.
Platelets: ≥ 100 000/µL iii. Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be
met without packed red blood cell (pRBC) transfusion within the prior 2 weeks.
Participants can be on stable dose of erythropoietin (≥ approximately 3 months. iv.
Leukocytes (WBC) > 3.0 b. Renal laboratory values i. Glomerular Filtration Rate (GFR):
>60 ml/min (Cockcroft-Gault formula). c. Hepatic laboratory values i. Total bilirubin:
≤1.5 × Upper Limit of Normal (ULN) OR direct bilirubin ≤ULN for participants with
total bilirubin levels >1.5 × ULN (excluding patients with Gilbert's Disease) ii.
Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT):
≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Patients must be willing to use adequate forms of contraception from screening, during
the trial, and for a minimum of 120 days after end of treatment, in accordance with
the following:
i. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be
used in addition to one of the following methods: Intrauterine devices or hormonal
contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings
or long-acting injections). ii. Women not of childbearing potential: Barrier
contraceptive method (i.e. condom) must be used.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
score of 0-1 at screening.
- Life expectancy longer than 3 months.
- Capable of understanding and complying with parameters as outlined in the protocol.
Exclusion Criteria:
- Has an active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) and inhaled and topical
treatments are not considered a form of systemic treatment and are allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study drug.
- Treated with any anti-cancer therapy within 30 days prior to the first virus
injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. surgery,
chemotherapy, immune-checkpoint inhibitors, kinase inhibitors, PARP inhibitors,
biological therapies, hormonal therapies, radiation, etc.). Continuation of hormonal
therapy or use of bone modifying agents (e.g. bisphosphonate or denosumab) is allowed
if started at least 3 months before.
- Participants must have recovered from all Adverse Events (AE)s due to previous
therapies to ≤Grade 1or baseline. Participants with ≤Grade 2 neuropathy may be
eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or
hormone replacement may be eligible. If the participant had major surgery, the
participant must have recovered adequately from the procedure and/or any complications
from the surgery prior to starting study intervention.
- Treated with a prior radiotherapy, including for palliative purposes, within 2 weeks
of start of study treatment (before or after). Participants must have recovered from
all radiation-related toxicities, not require corticosteroids, and not have had
radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
weeks of radiotherapy) to non-Central Nervous System (CNS) disease. Palliative
radiation is allowed from day 15 during the trial treatment period, if deemed
necessary by the investigator.
- Treated with a prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
Cytotoxic T lymphocyte-associated Antigen (CTLA)-4, Tumor necrosis factor receptor
superfamily, member 4 (OX40), CD137), and was discontinued from that treatment due to
a Grade 3 or higher immune-related Adverse Events (irAE).
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 30 days prior to the first virus
injection. An investigational agent is any drug or therapy that is currently not
approved for use in humans. Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the last
dose of the previous investigational agent.
- Uncontrolled cardiac or vascular diseases.
- History of myocardial infarction or cerebral stroke within the previous 12 months
before screening or is not sufficiently recovered from an older infarction or cerebral
stroke.
- History of severe hepatic dysfunction.
- History of hepatitis B (defined as HBsAg reactive), Hepatitis C (defined as hepatitis
C virus (HCV) RNA [qualitative] is detected) and/or HIV. No testing for Hepatitis B,
Hepatitis C and HIV is required unless mandated by a local health authority.
- History of coagulation disorder.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's
participation for the full duration of the study, or is not in the best interest of
the participant to participate, in the opinion of the treating investigator.
- Female patients who are pregnant, breastfeeding or intend to become pregnant. Women of
childbearing potential who has a positive urine pregnancy test (within 72 hours) prior
to treatment. If the urine test is positive or cannot be confirmed as negative, a
serum pregnancy test will be required.
- Has a known additional malignancy that is progressing or has required active treatment
within the past 5 years. Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 3 months by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.
- Has an active infection requiring systemic therapy.
- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
- Has a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study.
- Allergy to ingredients present in the investigational medicinal products (ingredients
are listed in the protocol) ie. severe hypersensitivity (≥Grade 3) to pembrolizumab
and/or any of its excipients.
- Known contraindications to pembrolizumab.
- Has had an allogenic tissue/solid organ transplant.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose
of study intervention. Administration of killed vaccines are allowed.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.