For Healthcare Professionals

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab


About the study

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  2. At least one measurable and injectable lesion
  3. Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
  4. Have a predicted life expectancy of ≥ 3 months
  5. Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
  6. Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy.
  7. Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment.
  8. Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
  9. Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment.


Exclusion Criteria:

  1. Prior treatment with an oncolytic therapy
  2. History of viral infections according to the protocol
  3. Prior complications with herpes infections
  4. Chronic use of anti-virals
  5. Uncontrolled/untreated brain metastasis
  6. History of interstitial lung disease
  7. History of non-infectious pneumonitis
  8. History of clinically significant cardiovascular disease
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-781-222-9570Email iconEmail Study Center

Study’s details


Cancer,Melanoma (Skin),Mismatch Repair Deficiency,Microsatellite Instability,Non-melanoma Skin Cancer,Cutaneous Melanoma,NSCLC

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Nov 30, 2024

Treatment type



Replimune Inc. identifier


Study number


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