A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

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Brief Title

A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

Official Title

A Phase 2, Two-stage, Study of Mirvetuximab Soravtansine (IMGN853) in Combination With Pembrolizumab in Patients With Microsatellite Stable (MSS) Recurrent or Persistent Endometrial Cancer (EC)

Brief Summary

      This research study is studying a drug combination as a possible treatment for endometrial
      cancer.

      The drugs involved in this study are:

        -  mirvetuximab soravtansine (IMGN853)

        -  pembrolizumab
    

Detailed Description

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug to learn whether the drug works in treating a
      specific disease. "Investigational" means that the drug is being studied.

      The FDA (the U.S. Food and Drug Administration) has not approved mirvetuximab soravtansine as
      a treatment for any disease.

      The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this
      specific disease but it has been approved for other uses.

      In this research study, the investigators are studying the combination of mirvetuximab
      soravtansine and pembrolizumab. Pembrolizumab is an immunotherapy that activates a patient's
      own immune system to recognize and kill tumor cells. Pembrolizumab by itself may not be
      enough to kill cancer cells in all people with cancer. In this study, all patients will
      receive mirvetuximab soravtansine and pembrolizumab. Mirvetuximab soravtansine is an
      antibody-drug conjugate. That is a type of agent that attaches a chemotherapy drug to a
      molecule that binds a protein on the outside of cancer cells. The protein targeted by
      mirvetuximab soravtansine is called folate receptor-alpha (FRα). FRα is expressed on the
      surface of certain cancers, including endometrial cancer cells. Mirvetuximab soravtansine is
      expected to kill cancer cells by delivering chemotherapy to cells that have high levels of
      FRα. To participate in this study, a sample of your tumor was previously tested, and was
      found to have high levels of FRα. Mirvetuximab soravtansine also may also active immune cells
      and improve the response to immunotherapies like pembrolizumab.

      In this study, the investigators expect to learn whether the combination of pembrolizumab and
      mirvetuximab soravtansine can shrink endometrial cancers or prevent their growth for at least
      6 months. The investigators will also learn more about the side effects patients experience
      who receive this treatment. The investigators also plan to learn more about which patients
      are likely to benefit from this treatment
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate

Secondary Outcome

 Duration of response

Condition

Endometrial Cancer

Intervention

Pembrolizumab

Study Arms / Comparison Groups

 IMGN853 + Pembrolizumab
Description:  Pembrolizumab is administered intravenously once every 3 weeks
IMGN853 is administered intravenously once every 3 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

35

Start Date

January 2, 2020

Completion Date

October 1, 2023

Primary Completion Date

October 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have advanced or recurrent serous endometrial cancer. In addition,
             the tumors must be:

          -  microsatellite stable (MSS) as documented by either intact immunohistochemical (IHC)
             nuclear expression of the mismatch repair genes MSH2, MSH6, MLH1 and PMS2; or
             microsatelitte stable by polymerase chain reaction (PCR), next generation sequencing,
             or other CLIA-approved method;

        AND

          -  FRα positive by central immunohistochemistry (IHC, Section 9.1). If archival tissue
             does not meet FRα criteria, a fresh biopsy tumor sample may be submitted and used to
             meet this criterium. If a fresh tumor biopsy cannot be done safely the patient will
             not be allowed to enroll on this study.

               -  Participants must have measurable disease as defined by RECIST 1.1. Lesions
                  situated in a previously irradiated area are considered measurable if progression
                  has been demonstrated in such lesions.

               -  Prior therapy: Patients must have had one, but no more than three lines of
                  chemotherapy for endometrial carcinoma.

          -  Prior hormonal therapy is allowed (no washout period is required after hormonal
             therapy) and does not count as a prior line of therapy. Hormonal therapy in
             combination with CDK4/6 inhibitors or mTOR or other PI3K-pathway inhibitors is allowed
             and does not count as a line of prior therapy.

          -  Patients must NOT have received any class of drugs targeted to the PD-1/PD-L1 pathway
             or folate receptor orthologs.

               -  Age 18 or greater years. Because insufficient dosing or adverse event data are
                  currently available on the use of mirvetuximab soravtansine and pembrolizumab in
                  participants <18 years of age, children are excluded. Endometrial cancer is rare
                  in the pediatric population.

               -  ECOG performance status 0 or 1

               -  Participants must have normal organ and marrow function as defined below:

          -  leukocytes ≥3,000/mcL

          -  absolute neutrophil count ≥1,500/mcL

          -  platelets ≥100,000/mcL

          -  hemoglobin ≥ 9.0 g/dL

          -  total bilirubin ≤ 1.5 x institutional upper limit of normal

          -  AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

          -  creatinine ≤ institutional upper limit of normal OR

          -  creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above
             institutional normal.

             -Time from prior therapy:

          -  Systemic anti-neoplastic therapy: 5 half-lives or 4 weeks, whichever is shorter.
             Hormonal therapy is not considered anti-neoplastic therapy.

          -  Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed
             at least 4 weeks, or focal radiation completed at least 2 weeks, prior to starting
             study treatment

               -  The effects of agents used in this study on the developing human fetus are
                  unknown. For this reason, women of child-bearing potential must agree to use
                  adequate contraception (hormonal or barrier method of birth control; abstinence)
                  prior to study entry, during study treatment, and for at least twelve weeks after
                  the last dose of study treatment. Should a woman become pregnant or suspect she
                  is pregnant while she is participating in this study, she should inform her
                  treating physician immediately.

               -  Women of child-bearing potential must have a negative serum pregnancy test within
                  3 days prior to the first dose of study treatment.

               -  Ability to understand and the willingness to sign a written informed consent
                  document

        Exclusion Criteria:

          -  Participants who have had chemotherapy within 5 half-lives or 4 weeks (whichever is
             shorter) or radiotherapy within 2 weeks prior to entering the study. Patients
             completing wide-field radiotherapy (e.g. >30% of marrow-bearing bones) must not have
             had treatment within 4 weeks prior to entering study. Participants must have recovered
             from all AEs due to previous therapy to Grade 1 ≤ or baseline, except alopecia.

          -  Participants who are receiving any other investigational agents.

          -  Prior exposure to agents targeting the PD-1/PD-L1 pathway.

          -  Required use of folate-containing supplements (e.g. folate deficiency).

          -  Known active CNS metastases and/or carcinomatous meningitis. Participants with
             previously treated brain metastases may participate provided they are radiologically
             stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging
             (note that the repeat imaging should be performed during study screening), clinically
             stable and without requirement of steroid treatment for at least 14 days prior to
             first dose of study treatment.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to monoclonal antibodies (including antibody drug-conjugates or checkpoint
             inhibitors).

          -  Uncontrolled intercurrent illness including, but not limited to, any of the following
             within 6 months of first study treatment: symptomatic congestive heart failure,
             unstable angina pectoris, uncontrolled hypertension (≥ Grade 3), hypertensive crisis
             or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, thrombotic or
             ischemic stroke, clinically-significant vascular disease (e.g. aortic aneurysm, or
             dissecting aneurysm), severe aortic stenosis, clinically significant peripheral
             vascular disease, or ≥ Grade 3 cardiac toxicity following prior chemotherapy, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Active or chronic corneal disorder, including but not limited to the following:
             Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal
             transplantation, active herpetic keratitis, and also active ocular conditions
             requiring on-going treatment/monitoring such as wet age-related macular degeneration
             requiring intravitreal injections, active diabetic retinopathy with macular edema,
             presence of papilledema, and acquired monocular vision.

          -  Serious clinically-relevant active infection, including known HIV infection,
             varicella-zoster virus, cytomegalovirus infection, has a known history of Hepatitis B
             (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C
             virus (defined as HCV RNA is detected) or any other known concurrent infectious
             disease requiring IV antibiotics with within 2 weeks of study enrollment are
             ineligible because of the potential for immune side effects.

          -  Has received a live vaccine within 30 days prior to the first dose of study drug.
             Examples of live vaccines include, but are not limited to, the following: measles,
             mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
             Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection
             are generally killed virus vaccines and are allowed; however, intranasal influenza
             vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

          -  Current or prior use of immunosuppressive medication within 7 days prior to enrollment
             with the following exceptions to this exclusion criterion:

               -  Intranasal, inhaled, topical steroids, or local steroid injections (eg,
                  intra-articular injection);

               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
                  prednisone or equivalent;

               -  Steroids as premedication for hypersensitivity reactions (eg, CT scan
                  premedication).

          -  Active autoimmune disease that might deteriorate when receiving an immunostimulatory
             agent. Patients with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid
             disease not requiring immunosuppressive treatment are eligible.

          -  Has a history of (non-infectious) pneumonitis that required steroids or has current
             pneumonitis.

          -  Pregnant or nursing women are excluded from this study because effects of agents used
             in this study on infants or the developing human fetus are unknown

          -  Presence of other malignancies unless they are considered cured by patient's
             oncologist
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jennifer Veneris, MD,PhD, 877-338-7425, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03835819

Organization ID

18-602


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 ImmunoGen, Inc.

Study Sponsor

Jennifer Veneris, MD,PhD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

June 2020