This is a Trial of MG1-E6E7 With Ad-E6E7 and Atezolizumab in Patients With HPV Associated Cancers
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/13/2018 |
Start Date: | June 21, 2018 |
End Date: | June 2022 |
Contact: | Tara Hollister - Clinical Trial Assistant |
Email: | tara.hollister@turnstonebio.com |
Phone: | 613-983-8272 |
Phase 1/1b, Multicenter, Open-label Trial of Oncolytic MG1 Virus (MG1-E6E7) With Adenovirus Vaccine (Ad-E6E7) Both Expressing Mutant Human Papilloma Virus (HPV) E6 and E7 and Atezolizumab in Pts With HPV Assoc. Cancers
This is a Phase 1/1b open-label dose escalation trial of Ad/MG1-E6E7 and sequential treatment
with atezolizumab in patients with HPV associated cancers. This study will consist of two
arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish
initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD).
- Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7
priming and subsequent treatment with IV atezolizumab.
- Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming
and subsequent treatment with IV atezolizumab.
In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as
determined in Phase 1 in order to more thoroughly explore immune response,
pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV
positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+
tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).
with atezolizumab in patients with HPV associated cancers. This study will consist of two
arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish
initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD).
- Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7
priming and subsequent treatment with IV atezolizumab.
- Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming
and subsequent treatment with IV atezolizumab.
In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as
determined in Phase 1 in order to more thoroughly explore immune response,
pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV
positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+
tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).
Key Inclusion Criteria:
- Histologically or cytologically confirmed recurrent or metastatic HPV associated tumor
(cervical, oropharyngeal, vulvar, vaginal, anal, or penile) with documented disease
progression.
- Arm 1, Phase 1 dose escalation: Cervical, HPV+ oropharyngeal, vulvar, vaginal, anal,
or penile
- Arm 1, Cohort A: Cervical cancer
- Arm 1, Cohort B: HPV+ Oropharyngeal cancer
- Arm 2 Phase 1 dose escalation and Cohort C: Cervical, oropharyngeal, vulvar, vaginal,
anal, or penile
- Failed, refused or intolerant to systemic therapy
- Measurable disease based on RECIST 1.1
- At least one tumor mass amenable to core needle biopsy
- Arm 2 only: At least one tumor judged as being safely injectable
- ECOG performance status 0 or 1
- Demonstrate adequate organ function
- Additional Inclusion criteria exist
Key Exclusion Criteria:
- Prior systemic therapy within 4 weeks.
- Patients receiving prior XRT must have recovered from any acute toxicity.
- Currently receiving/received experimental therapy within 4 weeks.
- Prior treatment with any HPV vaccine therapy for cancer.
- Requires use of anti-platelet or anti-coagulant therapy that cannot be safely
suspended for per protocol biopsies or intra-tumoral injections.
- Known active CNS metastases and/or carcinomatous meningitis.
- Clinically significant tumor invasion/ rapidly accumulating ascites, pericardial or
pleural effusions.
- Active infection requiring systemic therapy.
- Active autoimmune disease that has required systemic therapy in the past 2 years.
- Conditions likely to have resulted in splenic dysfunction.
- Known HIV/AIDS, active HBV or HCV infection.
- Received prior treatment with vesicular stomatitis (VSV) viral vector.
- Received immunosuppressive medication within 4 weeks. (>10mg/day prednisone)
- ≥ Grade 2 dyspnea and/or require supplemental oxygen
- Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy
- Additional Exclusion criteria exist
Exclusion Criteria Household Contacts:
- Patients with household contacts meeting any of the following criteria are ineligible
for study entry unless alternate living arrangements can be made, while under contact
precautions.
- Women who are pregnant or nursing an infant
- Children < 1 year old
- Individuals who are severely immunocompromised
- Contact precautions are from initial treatment with MG1-E6E7 to 7 days after the last
dose of MG1-E6E7
We found this trial at
6
sites
Toledo, Ohio 43614
Principal Investigator: John Nemunaitis, MD
Phone: 419-383-6962
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University of Miami A private research university with more than 15,000 students from around the...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Hamilton, Ontario
Principal Investigator: Sebastien Hotte, MD
Phone: 905-387-9711
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Bonnie Glisson, MD
Phone: 713-745-9919
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Dmitriy Zamarin, MD
Phone: 646-888-5097
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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