Phase
Condition
Cancer
Treatment
RP2
nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing and able to participate and comply with all trial requirements and able toprovide signed and dated informed consent prior to initiation of any trialprocedures
Male or Female ≥ 18 years of age
Patients with advanced or metastatic non-neurological solid tumors, who haveprogressed on standard therapy or cannot tolerate standard therapy, or for whichthere is no standard therapy preferred to enrolment in a clinical trial
Consent to provide archival tumour biopsy samples within 6 months, or a fresh tumourbiopsy is needed. Patients must also consent to provide on-treatment biopsies as perprotocol
At least one measurable and injectable tumor of ≥ 1 cm in longest diameter (orshorter diameter for lymph nodes).
Women of child-bearing potential (WOCBP) must have a negative urine pregnancy testat screening and a negative urine pregnancy test prior to administration of eachdose of RP2 or nivolumab
WOCBP must agree to use adequate birth control throughout their participation andfor 3 months after RP2 alone and 5 months after nivolumab last study treatment
Males with partners of child-bearing potential must agree to use adequate birthcontrol throughout their participation and for 3 months for RP2 alone and 7 monthsafter nivolumab last study treatment
Have laboratory values (obtained ≤ 28 days prior to first infusion day) inaccordance with the study protocol
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Cohort 2a only:
Baseline ECG that does not show abnormalities according to the protocol
Baseline troponin < 0.06 ng/mL
Baseline oxygen saturation levels that do not show abnormalities according to theprotocol
Cohort 2b and Part 3 only:
Patients in Cohort 2b should have histologically or cytologically confirmeddiagnosis of advanced or metastatic uveal melanoma, lung cancer, breast cancer, orgastrointestinal cancers (including but not limited to colorectal cancer [CRC] [microsatellite stable], gastric cancer, gastroesophageal junction cancer, andoesophageal cancer) (n=30)
Patients with HCC and a diagnosis of hepatitis B must be off antiviral therapy forat least 4 weeks prior to enrollment.
Patients with acute or chronic hepatitis B or C must be expected to not requireantiviral therapy during the RP2 treatment period.
Patients with HCC who have evidence of acute or chronic hepatitis C infection musthave completed treatment for hepatitis C at least 1 month prior to study enrollment
Patients in Part 3 should have solid tumours (excluding skin cancers) that theinvestigator deems suitable for RP2 monotherapy, including at least 10 patients withliver metastases from prevalent tumour types (e.g. lung, breast [including recurrentchest wall], and gastrointestinal cancers [colorectal, gastric, and oesophagealcancers]) (n=15)
Patient has progressed during or after one to three prior systemic anticancertherapies for advanced or metastatic disease or during or within six months ofreceiving adjuvant therapy. Patients who, in the opinion of the investigator, aredeemed not appropriate candidates for standard-of-care systemic anticancer therapyfor advanced or metastatic disease, or who, after documented consultation with theirtreating physician, refuse standard-of-care systemic anticancer therapy may beeligible after discussion with the medical monitor
Exclusion
Exclusion Criteria:
Prior treatment with an oncolytic virus therapy
History of viral infections according to the protocol
Systemic infection requiring IV antibiotics within 14 days prior to dosing
Prior complications with herpes infections
Chronic use of anti-virals
Systemic therapies for cancer within five half-lives or 4 weeks of first dose;whichever is shorter
Conditions that require certain doses of steroids (some doses and types will bepermitted)
Known active brain metastases - previously treated brain metastases may be permitted
Major surgery ≤ 2 weeks prior to starting study drug
Prior malignancy active with the previous 3 years; except for locally curablecancers that have apparently been cured
Female who has a positive urine pregnancy test or is breast-feeding or planning tobecome pregnant during study treatment and 90 days for RP2 alone or 5 months for RP2and nivolumab after the last dose of treatment
Participation in another clinical study within 4 weeks prior to the first dose
History of myocarditis or congestive heart failure (as defined by the New York HeartAssociation Functional Classification III or IV), or unstable angina, seriousuncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarctionwithin 6 months of randomization
History of allergy or sensitivity to study drug components
Has known psychiatric or substance abuse disorders that would interfere withcooperating with the requirements of the study
Part 2 patients only:
Participants with history of life-threatening toxicity related to prior immunetherapy except those that are likely to re-occur with standard countermeasures
Treatment with botanical preparations within 2 weeks prior to treatment
Certain autoimmune diseases, some types will be permitted
History of interstitial lung disease
Severe hypersensitivity to another monoclonal antibody
Has received radiotherapy within 2 weeks of start of study treatment
Has received a live vaccine within 28 days prior to first dose of study drug
History of non-infectious pneumonitis
History or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the study
Other serious or uncontrolled medical disorders
Cohort 2b and Part 3 (only for the subset of patients with liver metastases suitable and intended for injection)
Presence of liver metastases that are estimated to invade more than one-third of theliver
Macroscopic intravascular invasion into the main portal vein, hepatic vein or venacava
Significant bleeding event within the last 12 months that places the patient at riskfor intrahepatic intratumoral injection procedure based on investigator assessment
Prior chemoembolization, radioembolization, or other locoregional liver-directedprocedures to the lesion selected for intratumoral injection
Study Design
Study Description
Connect with a study center
Hospital Universitario d'Hebron
Barcelona, 119 08035
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 10 28050
SpainActive - Recruiting
Hospital Clinico de Valencia
Valencia, 46010
SpainActive - Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Merseyside CH63 4JY
United KingdomActive - Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United KingdomActive - Recruiting
Churchill Hospital
Oxford, OX3 9DU
United KingdomActive - Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomSite Not Available
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