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Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC

ConditionsHepatocellular CarcinomaBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorReplimune, Inc.

About this trial

The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and/or metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential and must agree to use a highly effective contraception method during the treatment period, and for at least (a) 90 days after the last dose of RP2 or (b) 5 months after the last dose of atezolizumab, or (c) 6 months after the last dose of bevacizumab, or (d) 90 days after the last dose of durvalumab, whichever is longer.

Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last dose of RP2: refrain from donating fresh unwashed sperm plus either be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) OR must agree to use an external condom and also should advise their partner to use a highly effective method of contraception as a condom may break or leak.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • RP2

    Biological/Vaccine

    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

  • Bevacizumab

    Biological/Vaccine

    Anti-VEGF therapy.

  • Atezolizumab

    Biological/Vaccine

    Anti-PD-L1 monoclonal antibody.

  • Durvalumab

    Biological/Vaccine

    Anti-PD-L1 monoclonal antibody

  • RP2 Monotherapy

    Biological/Vaccine

    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: RP2+Bevacizumab and AtezolizumabExperimental treatment 3 interventions
Group B: RP2 MonotherapyExperimental treatment 1 intervention
Group C: RP2+DurvalumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate per modified RECIST 1.1

The proportion of patients achieving a BOR of CR or PR per RECIST 1.1 among those that are evaluable for response.

Time frame
From Day 1 up to 3 years after first RP2 dose of last patient.

Secondary outcomes

1

Number of patients with treatment-emergent adverse events (TEAEs)

The incidence of all TEAEs

Time frame
From Day 1 up to 135 days after last dose.
2

ORR per RECIST modified for HCC (HCC mRECIST) for HCC cohort only

The proportion of patients achieving a BOR of CR or PR per HCC-mRECIST among those that are evaluable for response

Time frame
From Day 1 up to 3 years after first RP2 dose of last patient
3

Duration of response (DOR)

The time from a tumor response, either a CR or PR (whichever is recorded first), until the date of PD, which was subsequently confirmed, or with no further follow up, or death due to any cause, whichever occurs first.

Time frame
From Day 1 up to 3 years after first RP2 dose of last patient.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Replimune, Inc.

Lead sponsor

Source ClinicalTrials.gov
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