Study Stopped
Sponsor decision
Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
RAPTOR
A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
1 other identifier
interventional
27
3 countries
11
Brief Summary
To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2020
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
June 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2023
CompletedApril 23, 2025
April 1, 2025
2.6 years
March 4, 2020
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
25 months
Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) when combined with pembrolizumab
Percentage of patients with adverse events by severity as determined by NCI CTCAE v5.0
25 months
Maximum tolerated dose (MTD) or Maximum feasible dose (MFD) and determination of the recommended Phase 2 dose (RP2D) of TBio-6517 alone and in combination with pembrolizumab.
The highest dose of TBio-6517 that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation
4 weeks
Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D
Percentage of patients treated at the RP2D in combination with pembrolizumab with a partial response or complete response by RECIST 1.1 following central radiologist review
25 months
Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D
Percentage of patients treated at the RP2D with pembrolizumab with a partial response (PR) or complete response (CR) by iRECIST following central radiologist review
25 months
Secondary Outcomes (7)
Number and severity of adverse events at the RP2D
25 months
Median overall survival (OS)
48 months
Median Duration of Response (DoR)
25 months
Proportion of patients with a response (ORR)
25 months
Median Disease Control Rate (DCR)
25 months
- +2 more secondary outcomes
Study Arms (8)
Arm A: TBio-6517 alone
EXPERIMENTALDose escalation of TBio-6517 alone administered by direct injection into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months.
Arm B: TBio-6517 and Pembrolizumab
EXPERIMENTALDose escalation of TBio-6517 administered in combination with pembrolizumab. TBio-6517 will be directly injected into tumor(s) x 4. Booster injections of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.
TBio-6517 and Pembrolizumab in MSS-CRC
EXPERIMENTALDoses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with microsatellite stable colorectal carcinoma (MSS-CRC). Booster injections of TBio-6517 are permitted for up to 24 months.
TBio-6517 and Pembrolizumab in cutaneous melanoma
EXPERIMENTALDoses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with malignant melanoma of the skin. Booster injections of TBio-6517 are permitted for up to 24 months.
TBio-6517 and Pembrolizumab in cutaneous squamous cell carcinoma of the skin
EXPERIMENTALDoses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 8 given every 3 weeks for up to 24 months in patients with cSCC. Booster injections of TBio-6517 are permitted for up to 24 months.
TBio-6517 and Pembrolizumab in HPV positive head and neck cancer
EXPERIMENTALDoses of TBio-6517 will be administered by direct injection into tumor(s) x 4 in combination with pembrolizumab beginning at Day 9 given every 3 weeks for up to 24 months in patients with HPV associated oropharyngeal cancer. Booster injections of TBio-6517 are permitted for up to 24 months.
Arm C: TBio-6517 intravenous
EXPERIMENTALDose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months.
Arm D: TBio-6517 intravenous and Pembrolizumab
EXPERIMENTALDose escalation of TBio-6517 administered in combination with pembrolizumab. Dose escalation of TBio-6517 alone administered by intravenous infusion x 4. Booster infusions of TBio-6517 are permitted for up to 24 months. Pembrolizumab will be administered beginning at Day 9 via intravenous (IV) infusion every 3 weeks for up to 24 months.
Interventions
Engineered Oncolytic Vaccinia Virus
Immune checkpoint inhibitor.
Eligibility Criteria
You may qualify if:
- Have a histologically or pathologically documented, locally-advanced or metastatic solid tumor for which standard curative measures do not exist or are no longer effective
- Measurable disease as per RECIST 1.1 criteria
- At least one tumor amenable to safe ITu injections and biopsies
- ECOG performance status 0 or 1
- Demonstrate adequate organ function
- Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions
- For patients in phase 2 only: Have a histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumor listed below, that is incurable and for which prior standard treatment has failed:
- Advanced (unresectable) or metastatic, intra or extra hepatic adenocarcinoma originating from the bile duct, CCA (Cohort 1) having progressed on at least 1 line of systemic therapy (including targeted therapy if eligible)
- Locally advanced or metastatic cutaneous melanoma (Cohort 2) that has failed anti-PD-1 or anti-PDL1 therapy (+/- anti-CTLA-4 therapy) and if BRAF+, having failed a BRAF/ +/-MEK inhibitor
- Locally advanced or metastatic cSCC (Cohort 3) that has not received systemic therapy (e.g., local resection or local topical therapy is permitted).
- Locally advanced or metastatic MSS-CRC (Cohort 4) patients that have progressed on at least 2 prior lines of systemic therapy which should include irinotecan and oxaliplatin +/- targeted therapy if warranted.
You may not qualify if:
- Prior systemic therapy, including experimental, surgery or radiation therapy within 4 weeks and must have recovered from acute toxicity.
- Prior treatment with any oncolytic virus.
- Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
- CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
- Prior history of myocarditis
- Symptomatic or asymptomatic cardiovascular disease
- Known HIV/AIDS, active HBV or HCV infection.
- Received immunosuppressive medication within 4 weeks. (\>10mg/day prednisone)
- Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turnstone Biologics, Corp.lead
- Takedacollaborator
Study Sites (11)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Sylvester Comprehensive Cancer Center / UMHC
Miami, Florida, 33136, United States
University of Kansas Medical Center
Kansas City, Kansas, 66205, United States
Clinical Site 1007
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
The Billings Clinic
Billings, Montana, 31031, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Ottawa Hospital and Research Institute (OHRI)
Ottawa, Ontario, Canada
National Cancer Center
Ilsandong, 10408, South Korea
Seoul National University Hospital (SNUH)
Junggu, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ines Verdon, MD
Turnstone Biologics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 9, 2020
Study Start
June 2, 2020
Primary Completion
January 23, 2023
Study Completion
January 23, 2023
Last Updated
April 23, 2025
Record last verified: 2025-04