CancerPhase 1NCT04336241
Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors
A Phase 1 study testing RP2 and nivolumab in people with Cancer, run by Replimune, Inc. at 6 sites in 2 countries.
Trial summary
RP2-001-18 is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP2 in adult subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- RP2 and nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Oct 2019to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
- Male or Female ≥ 18 years of age
- Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for which there is no standard therapy preferred to enrolment in a clinical trial
- Consent to provide archival tumour biopsy samples within 6 months, or a fresh tumour biopsy is needed. Patients must also consent to provide on-treatment biopsies as per protocol
- At least one measurable and injectable tumor of ≥ 1 cm in longest diameter (or shorter diameter for lymph nodes).
- Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of RP2 or nivolumab
Show all 21Show fewer
- WOCBP must agree to use adequate birth control throughout their participation and for 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 birth control throughout their participation and for 3 months for RP2 alone and 7 months after nivolumab last study treatment
- Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance 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 the protocol
- Cohort 2b and Part 3 only:
- Patients in Cohort 2b should have histologically or cytologically confirmed diagnosis of advanced or metastatic uveal melanoma, lung cancer, breast cancer, or gastrointestinal cancers (including but not limited to colorectal cancer [CRC] [microsatellite stable], gastric cancer, gastroesophageal junction cancer, and oesophageal cancer) (n=30)
- Patients with HCC and a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment.
- Patients with acute or chronic hepatitis B or C must be expected to not require antiviral therapy during the RP2 treatment period.
- Patients with HCC who have evidence of acute or chronic hepatitis C infection must have 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 the investigator deems suitable for RP2 monotherapy, including at least 10 patients with liver metastases from prevalent tumour types (e.g. lung, breast [including recurrent chest wall], and gastrointestinal cancers [colorectal, gastric, and oesophageal cancers]) (n=15)
- Patient has progressed during or after one to three prior systemic anticancer therapies for advanced or metastatic disease or during or within six months of receiving adjuvant therapy. Patients who, in the opinion of the investigator, are deemed not appropriate candidates for standard-of-care systemic anticancer therapy for advanced or metastatic disease, or who, after documented consultation with their treating physician, refuse standard-of-care systemic anticancer therapy may be eligible after discussion with the medical monitor
Who cannot join
- 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
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- Conditions that require certain doses of steroids (some doses and types will be permitted)
- 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 curable cancers that have apparently been cured
- Female who has a positive urine pregnancy test or is breast-feeding or planning to become pregnant during study treatment and 90 days for RP2 alone or 5 months for RP2 and 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 Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction within 6 months of randomization
- History of allergy or sensitivity to study drug components
- Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
- Part 2 patients only:
- Participants with history of life-threatening toxicity related to prior immune therapy 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 abnormality that 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 the liver
- Macroscopic intravascular invasion into the main portal vein, hepatic vein or vena cava
- Significant bleeding event within the last 12 months that places the patient at risk for intrahepatic intratumoral injection procedure based on investigator assessment
- Prior chemoembolization, radioembolization, or other locoregional liver-directed procedures to the lesion selected for intratumoral injection
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain3 sites
Hospital Universitario d'Hebron
Barcelona, 119 08035
Hospital Universitario HM Sanchinarro
Madrid, 10 28050
Hospital Clinico de Valencia
Valencia, 46010
United Kingdom3 sites
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Merseyside, CH63 4JY
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Churchill Hospital
Oxford, OX3 9DU
About this study
Official title: An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors
RP2-001-18 is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP2 in adult subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Read the detailed description
RP2 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses an anti-CTLA-4 antibody and is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1, multicenter, open label, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP2 alone and in combination with nivolumab in adult subjects with advanced solid tumors.
The study will be conducted in two parts. The first part of the study is an open-label, dose escalation FIH Phase 1 study to assess the safety and tolerability of RP2 and to determine the recommended Phase 2 dose (RP2D) to be used in the second part of the study. The second part of the study is an open label design to further investigate safety of RP2 in combination with nivolumab. It will also assess the biological activity of multiple doses of RP2 in combination with nivolumab. An expansion to the second part of the study will include enrolment of a further 30 patients on RP2 in combination with nivolumab.
Following completion of the expansion in part 2, part 3 will enroll a further 15 patients on RP3 monotherapy.
The expansion to part 2 and part 3 will focus on patients with advanced or metastatic uveal melanoma, lung cancer, breast cancer or GI cancers and patients with liver metastasis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP2Biological
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation
nivolumabBiological
Also called Opdivo
Programmed death receptor (PD-1) blocking antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of RP2 - superficial tumors | Experimental | Dose escalation of RP2 alone in 3 cohorts with IT injections in superficial tumors. Receives: Biological: RP2 |
| Dose escalation of RP2 - deep/visceral tumors | Experimental | Dose escalation of RP2 alone in 3 cohorts with imaging guided IT injections in deep/visceral tumors. Receives: Biological: RP2 |
| Dose expansion of RP2 and nivolumab - superficial tumors | Experimental | Doses of RP2 (IT) in superficial tumors with nivolumab (IV). Receives: Biological: RP2; Biological: nivolumab |
| Dose expansion of RP2 and nivolumab - deep/visceral tumors | Experimental | Imaging guided doses of RP2 (IT) in deep/visceral tumors. Receives: Biological: RP2; Biological: nivolumab |
| Seronegative cohort | Experimental | Doses of RP2 (IT) in HSV seronegative participants. Receives: Biological: RP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events (AEs)
Percentage of subjects with AEs
Measured: From Day 1 up to 60 days after last dose
Percentage of serious adverse events (SAEs)
Percentage of subjects with SAEs
Measured: From Day 1 up to 60 days after last dose
Percentage of dose limiting toxicities (DLTs)
Percentage of subjects with DLTs
Measured: From Day 1 up to 30 days after last dose.
Percentage of treatment emergent adverse events (TEAEs)
Percentage of subjects with TEAEs
Measured: From Day 1 up to 60 days after last dose.
Percentage of TEAEs ≥ Grade 3
Percentage of subjects with TEAEs ≥ Grade 3
Measured: From Day 1 up to 60 days after last dose.
Percentage of events requiring withdrawal
Percentage of subjects experiencing events requiring withdrawal from treatment.
Measured: From Day 1 up to last dose (up to 8 weeks for dose escalation phase and up to 2 years for expansion phase)).
Maximum tolerated dose (MTD) of RP2
MTD on the safety and response data collected during the dose escalation phase (Part 1).
Measured: 7 months
Recommended Phase 2 dose (RP2D) of RP2
RP2D of RP2 based on the safety and response data collected during the dose escalation phase (Part 1).
Measured: 7 months
Secondary outcomes (10)
Percentage of biologic activity
Percentage of subjects with biological activity determined by tumor biopsies and biomarker data
Measured: 20 weeks
Percentage of subjects with detectable RP2
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of RP2.
Measured: 20 weeks
Change in HSV-1 antibody levels
Change in HSV-1 antibody levels during treatment compared to baseline
Measured: From Day 1 up to last dose (up to 4 months for dose escalation phase and up to 5.5 months for expansion phase)).
Percentage of overall response rate (ORR)
Percentage of ORR.
Measured: 3 years
Median duration of response
Median duration of response of subjects
Measured: 3 years
Median progression-free survival
Median duration of progression-free survival of subjects
Measured: 3 years
Median overall survival
Median overall survival rate of subjects
Measured: 3 years
Percentage of complete response (CR)
Percentage of subjects with a CR
Measured: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Percentage of partial response (PR)
Percentage of subjects with a PR
Measured: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Percentage of stable disease (SD)
Percentage of subjects with SD
Measured: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start17 Oct 2019
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1 - Dose Escalation - Patients will be enrolled into three sequential dose level cohorts. Part 2 - Dose expansion - Patients will receive a fixed dose of RP2 in combination with Nivolumab. Part 3 - Patients will receive four doses of RP2 monotherapy
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Replimune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Vanasse, MD, Study director, Replimune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336241
- Sponsor's protocol ID
- RP2-001-18
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04336241
- Acronym / sponsor ID
- RP2-001-18
- Conditions
- Cancer
- Keywords
- Uveal Melanoma, Gastrointestinal Cancers, Lung Cancer, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Replimune, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RP2-001-18 is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP2 in adult subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Detailed description
RP2 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses an anti-CTLA-4 antibody and is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1, multicenter, open label, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP2 alone and in combination with nivolumab in adult subjects with advanced solid tumors.
The study will be conducted in two parts. The first part of the study is an open-label, dose escalation FIH Phase 1 study to assess the safety and tolerability of RP2 and to determine the recommended Phase 2 dose (RP2D) to be used in the second part of the study. The second part of the study is an open label design to further investigate safety of RP2 in combination with nivolumab. It will also assess the biological activity of multiple doses of RP2 in combination with nivolumab. An expansion to the second part of the study will include enrolment of a further 30 patients on RP2 in combination with nivolumab.
Following completion of the expansion in part 2, part 3 will enroll a further 15 patients on RP3 monotherapy.
The expansion to part 2 and part 3 will focus on patients with advanced or metastatic uveal melanoma, lung cancer, breast cancer or GI cancers and patients with liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Part 1 - Dose Escalation - Patients will be enrolled into three sequential dose level cohorts. Part 2 - Dose expansion - Patients will receive a fixed dose of RP2 in combination with Nivolumab. Part 3 - Patients will receive four doses of RP2 monotherapy
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of RP2 - superficial tumors | Experimental | Biological: RP2Dose escalation of RP2 alone in 3 cohorts with IT injections in superficial tumors. |
| Dose escalation of RP2 - deep/visceral tumors | Experimental | Biological: RP2Dose escalation of RP2 alone in 3 cohorts with imaging guided IT injections in deep/visceral tumors. |
| Dose expansion of RP2 and nivolumab - superficial tumors | Experimental | Biological: RP2, Biological: nivolumabDoses of RP2 (IT) in superficial tumors with nivolumab (IV). |
| Dose expansion of RP2 and nivolumab - deep/visceral tumors | Experimental | Biological: RP2, Biological: nivolumabImaging guided doses of RP2 (IT) in deep/visceral tumors. |
| Seronegative cohort | Experimental | Biological: RP2Doses of RP2 (IT) in HSV seronegative participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
- Male or Female ≥ 18 years of age
- Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for which there is no standard therapy preferred to enrolment in a clinical trial
- Consent to provide archival tumour biopsy samples within 6 months, or a fresh tumour biopsy is needed. Patients must also consent to provide on-treatment biopsies as per protocol
- At least one measurable and injectable tumor of ≥ 1 cm in longest diameter (or shorter diameter for lymph nodes).
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP2Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation | Biological | Dose escalation of RP2 - deep/visceral tumors, Dose escalation of RP2 - superficial tumors, Dose expansion of RP2 and nivolumab - deep/visceral tumors, Dose expansion of RP2 and nivolumab - superficial tumors, Seronegative cohort |
| nivolumabAlso: OpdivoProgrammed death receptor (PD-1) blocking antibody | Biological | Dose expansion of RP2 and nivolumab - deep/visceral tumors, Dose expansion of RP2 and nivolumab - superficial tumors |
Primary outcome
Percentage of adverse events (AEs)
Time frame: From Day 1 up to 60 days after last dose
Percentage of subjects with AEs
Percentage of serious adverse events (SAEs)
Time frame: From Day 1 up to 60 days after last dose
Percentage of subjects with SAEs
Percentage of dose limiting toxicities (DLTs)
Time frame: From Day 1 up to 30 days after last dose.
Percentage of subjects with DLTs
Percentage of treatment emergent adverse events (TEAEs)
Time frame: From Day 1 up to 60 days after last dose.
Percentage of subjects with TEAEs
Percentage of TEAEs ≥ Grade 3
Time frame: From Day 1 up to 60 days after last dose.
Percentage of subjects with TEAEs ≥ Grade 3
Percentage of events requiring withdrawal
Time frame: From Day 1 up to last dose (up to 8 weeks for dose escalation phase and up to 2 years for expansion phase)).
Percentage of subjects experiencing events requiring withdrawal from treatment.
Maximum tolerated dose (MTD) of RP2
Time frame: 7 months
MTD on the safety and response data collected during the dose escalation phase (Part 1).
Recommended Phase 2 dose (RP2D) of RP2
Time frame: 7 months
RP2D of RP2 based on the safety and response data collected during the dose escalation phase (Part 1).
10 secondary outcomes
Percentage of biologic activity
Time frame: 20 weeks
Percentage of subjects with detectable RP2
Time frame: 20 weeks
Change in HSV-1 antibody levels
Time frame: From Day 1 up to last dose (up to 4 months for dose escalation phase and up to 5.5 months for expansion phase)).
Percentage of overall response rate (ORR)
Time frame: 3 years
Median duration of response
Time frame: 3 years
Median progression-free survival
Time frame: 3 years
Median overall survival
Time frame: 3 years
Percentage of complete response (CR)
Time frame: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Percentage of partial response (PR)
Time frame: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Percentage of stable disease (SD)
Time frame: From Day 1 up to last dose (up to 8 weeks for escalation phase and up to 2 years for expansion phase).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Vanasse, MD study director
Replimune, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP2 and nivolumab in people with Cancer, run by Replimune, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (AEs) (time frame: From Day 1 up to 60 days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.