- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370587
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: ImmVira Pharma Co. LTD
- Phone Number: 781-718-5121
- Email: clinicaltrials@immviragroup.com
Study Locations
-
-
-
Bedford Park, Australia
- Recruiting
- Southern Oncology
-
Contact:
- Ganessan Kichenadasse
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- Ganessan Kichenadasse
-
Frankston, Australia
- Recruiting
- Peninsula & South Eastern Haematology and Oncology Group
-
Contact:
- Vinod Ganju
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- Vinod Ganju
-
Melbourne, Australia
- Recruiting
- The Alfred
-
Contact:
- Andrew Haydon
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- Andrew Haydon
-
-
-
-
Arizona
-
Gilbert, Arizona, United States, 85234
- Recruiting
- Banner MD Anderson Cancer Center
-
Contact:
- Jiaxin Niu, MD, PhD
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- Jiaxin Niu, MD, PhD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Howard Kaufman, MD
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- Howard Kaufman, MD
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
Principal Investigator:
- Elizabeth Buchbinder, MD
-
Contact:
- Elizabeth Buchbinder, MD
- Email: clinicaltrials@immviragroup.com
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Medical Center
-
Contact:
- John Kirkwood, MD
- Email: clinicaltrials@immviragroup.com
-
Principal Investigator:
- John Kirkwood, MD
-
-
Texas
-
Dallas, Texas, United States, 75230
- Recruiting
- Mary Crowley Cancer Research
-
Principal Investigator:
- Minal Barve, MD
-
Contact:
- Minal Barve, MD
- Email: clinicaltrials@immviragroup.com
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Recruiting
- Virginia Cancer Specialists
-
Contact:
- Alexander Spira, MD
- Email: clinicaltrials@immviragroup.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Age 18 years or older.
- Disease progression after standard of care (SOC) therapy or in the opinion of
The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.
Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination.
iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
- Measurable disease per RECIST version 1.1.
- Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy > 12 weeks.
- Demonstrate adequate organ function as defined by acceptable laboratory testing results.
- Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.
- Last dose of previous anticancer therapy ≥ 21 days, radiotherapy > 21 days, or surgical intervention > 21 days prior to the first dose of T3011.
- Recovered from all prior anticancer therapy toxicities.
- Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
- Capable of understanding and complying with protocol requirements.
- Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.
Key Exclusion Criteria:
- Have only uninjectable tumors..
- Patients with injectable tumors impinging upon major airways or blood vessels.
- HNSCC only: Prior re-irradiation field containing carotid artery.
- Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.
- Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
- Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
- Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
- Requires continued concurrent therapy with any drug active against HSV.
- Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
- Primary or acquired immunodeficient states.
- Pregnant or lactating.
- Prior organ transplantation.
- Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
- Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
- History of or current central nervous system metastases.
- History of seizure disorders within 6 months of Screening.
- Active oral or skin herpes lesion at Screening.
- Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.
- History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
18. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention.
22. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and/or interpretation of the current study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1
T3011 single agent dose escalation in participants with solid tumors
|
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
|
Experimental: Phase 2a Part 1 Arm A
RP2D T3011 single agent in participants with melanoma
|
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
|
Experimental: Phase 2a Part 1 Arm B
RP2D T3011 single agent in participants with other solid tumors
|
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
|
Experimental: Phase 2a Part 2 Arm C
RP2D T3011 + pembrolizumab in participants with NSCLC
|
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
|
Experimental: Rollover Arm
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
|
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of escalating doses T3011
Time Frame: Up to 2 years from first dose of T3011
|
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
|
Up to 2 years from first dose of T3011
|
To determine the dose(s) of T3011 to be examined in Phase 2a
Time Frame: Through the first two T3011 injections (approximately 28 days)
|
Incidence of DLTs
|
Through the first two T3011 injections (approximately 28 days)
|
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
Time Frame: Up to 2 years from first dose of T3011
|
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
|
Up to 2 years from first dose of T3011
|
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Time Frame: Up to 2 years from first dose of T3011
|
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
|
Up to 2 years from first dose of T3011
|
Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone
Time Frame: Up to 2 years from first dose of T3011
|
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
|
Up to 2 years from first dose of T3011
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Up to 2 years from first dose of T3011
|
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
|
Up to 2 years from first dose of T3011
|
Disease control rate (DCR)
Time Frame: Up to 2 years from first dose of T3011
|
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
|
Up to 2 years from first dose of T3011
|
Duration of response (DOR)
Time Frame: Up to 2 years from first dose of T3011
|
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years from first dose of T3011
|
Progression-free survival (PFS)
Time Frame: Up to 2 years from first dose of T3011
|
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
|
Up to 2 years from first dose of T3011
|
Durable response (DR)
Time Frame: Up to 2 years from first dose of T3011
|
DR is defined as objective response (CR or PR) according to RECIST v1.1 and iRECIST.
|
Up to 2 years from first dose of T3011
|
Overall Survival (OS)
Time Frame: Up to 1 year after last dose of T3011
|
OS is defined as the time from enrollment to death from any cause.
|
Up to 1 year after last dose of T3011
|
Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development
Time Frame: Up to 2 years from first dose of T3011
|
To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 given as single agent and in combination with pembrolizumab post injection.
|
Up to 2 years from first dose of T3011
|
Presence and frequency of T3011 in injection site swab, saliva, and urine
Time Frame: Up to 2 years from first dose of T3011
|
To evaluate the virus shedding of T3011 following intratumoral injection
|
Up to 2 years from first dose of T3011
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Neoplasms, Squamous Cell
- Neoplasms
- Sarcoma
- Melanoma
- Carcinoma, Squamous Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- CTIV1708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on T3011
-
Shanghai Pharmaceuticals Holding Co., LtdRecruitingAdvanced Solid TumorsChina
-
ImmVira Pharma Co. LtdRecruitingLymphoma | Lung Cancer | Advanced Solid Tumor | Liver Cancer | Mesothelioma of PleuraChina
-
Shanghai Pharmaceuticals Holding Co., LtdRecruiting
-
West China HospitalRecruiting
-
ImmVira Pharma Co. LtdRecruitingSarcoma | Breast Cancer | NSCLC | Advanced Solid Tumor | HNSCC | Esophagus Cancer | Non-melanoma Skin CancerChina
-
ImmVira Pharma Co. LtdActive, not recruitingHepatocellular Carcinoma | Colorectal Cancer | Ovarian Cancer | NSCLC | Solid Tumor | Endometrial CancerUnited States
-
ImmVira Pharma Co. LtdSuspendedMelanoma | Malignant MelanomaUnited States
-
West China HospitalRecruitingAdvanced Colorectal CancerChina
-
China Medical University, ChinaImmvira Co., LimitedNot yet recruitingColorectal Cancer Metastatic