A Study of MG1-E6E7 with Ad-E6E7 and Atezolizumab in Patients with HPV Associated Cancers

Overview

About this study

The purpose of this study is to determine the safety, toxicity and maximum tolerated dose (MTD) / maximum feasible dose (MFD) of Ad/MG1-E6E7, and sequential treatment with atezolizumab in patients with HPV associated cancers.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions