Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma

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Brief Title

Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

Official Title

A Phase 1/2 Study Using Nivolumab and ABI-009 for Advanced Sarcoma, Advanced Carcinoma Treated With PD1 Inhibitors, and Tumors With Genetic Mutations Sensitive to mTOR Inhibitors

Brief Summary

      This study investigates the safety/toxicity and potential anti-tumor activity of sequential
      administration of nivolumab and escalating doses of the mTOR inhibitor ABI-009 in advanced
      Ewing's sarcoma, PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung
      cancer, small cell lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma,
      squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's
      lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations
      sensitive to mTOR inhibitors
    

Detailed Description

      The primary objective of this study is to investigate the maximum tolerated dose of ABI-009,
      an mTOR inhibitor, when given sequentially with nivolumab in advanced Ewing's sarcoma,
      PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell
      lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of
      head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic
      colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors

      The secondary objectives are to investigate the disease control rate (DCR) and progression
      free survival (PFS) using nivolumab/ABI-009 combination therapy in advanced Ewing's sarcoma,
      PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell
      lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of
      head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic
      colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors

      The exploratory objectives are (1) To correlate progression free survival (PFS) based on
      Immune-related Response Criteria (irRECIST) with that based on RECIST v1.1, and (2) To
      correlate PFS with PD-1 and PD-L1 expression in patients' tumors.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Disease control rate

Condition

Ewing Sarcoma

Intervention

Nab-Rapamycin

Study Arms / Comparison Groups

 Arm 1
Description:  This is an open label, dose-seeking phase 1b study using a defined dose of nivolumab and escalating doses of Nab-Rapamycin (ABI-009) given intravenously.
I. Dose Escalation Phase 1 Part of Study: The study will employ the standard "cohort of three" design. No intra-patient dose escalation will take place.
II. Expansion Phase 1b Part of Study: Following dose escalation, an additional 22-28 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.

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

40

Start Date

August 24, 2017

Completion Date

April 1, 2022

Primary Completion Date

December 1, 2021

Eligibility Criteria

        Inclusion Criteria:

        A patient will be eligible for inclusion in this study only if all of the following
        criteria are met:

          1. Patients must have a histologically confirmed diagnosis of Ewing's sarcoma, PEComa,
             epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell
             lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell
             carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma,
             MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive
             to mTOR inhibitors, that is either metastatic or locally advanced and for which
             surgery is not a recommended option.

          2. Patients must have one or more measurable target lesions by CT scan or MRI. Measurable
             disease by RECIST v1.1.

          3. Patients must not have been previously treated with a PD-1 inhibitor in combination
             with an mTOR inhibitor.

          4. Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or
             other therapeutic agents (except immunotherapy and mTOR inhibitors) is allowed, if
             completed after 5 half-lives or ≥28 days prior to enrollment, whichever is shorter.

          5. Eligible patients, 12 years or older, with Eastern Cooperative Oncology Group (ECOG)
             performance status 0 or 1.

          6. Patients must have the following blood chemistry levels at screening (obtained ≤14
             days prior to enrollment (local laboratory):

               1. total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dl

               2. AST ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)

               3. serum creatinine ≤1.5 x ULN

          7. Adequate biological parameters as demonstrated by the following blood counts at
             screening (obtained ≤14 days prior to enrollment, local laboratory):

               1. Absolute neutrophil count (ANC) ≥1.5 × 109/L;

               2. Platelet count ≥100,000/mm3 (100 × 109/L);

               3. Hemoglobin ≥9 g/dL.

          8. Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL.

          9. Male or non-pregnant and non-breast feeding female:

             Females of child-bearing potential must agree to use effective contraception without
             interruption from 28 days xprior to starting IP and while on study medication and have
             a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing
             pregnancy testing during the course of the study, and after the end of study
             treatment. A second form of birth control is required even if she has had a tubal
             ligation.

             Male patients must practice abstinence or agree to use a condom during sexual contact
             with a pregnant female or a female of childbearing potential while participating in
             the study. A second form of birth control is required even if he has undergone a
             successful vasectomy.

         10. Life expectancy of >3 months, as determined by the investigator.

         11. Ability to understand and sign informed consent.

         12. Willingness and ability to comply with scheduled visits, laboratory tests, and other
             study procedures.

        Exclusion Criteria:

        A patient will not be eligible for inclusion in this study if any of the following criteria
        apply:

          1. Concurrent or prior immunotherapy with a PD-1 inhibitor in combination with an mTOr
             inhibitor.

          2. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A
             patient with controlled and asymptomatic CNS metastases may participate in this study.
             As such, the patient must have completed any prior treatment for CNS metastases ≥28
             days (including radiotherapy and/or surgery) prior to start of treatment in this study
             and should not be receiving chronic corticosteroid therapy for the CNS metastases.

          3. Active gastrointestinal bleeding.

          4. Pre-existing thyroid abnormality is allowed provided thyroid function can be
             controlled with medication.

          5. Uncontrolled serious medical or psychiatric illness. Patients with a "currently
             active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of
             the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and
             postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are
             ineligible. Patients are not considered to have a "currently active" malignancy if
             they have completed therapy and are free of disease for ≥1 year).

          6. Liver-directed therapy within 2 months of enrollment. Prior treatment with
             radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial
             embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if
             these therapies did not affect the areas of measurable disease being used for this
             protocol.

          7. Recent infection requiring systemic anti-infective treatment that was completed ≤14
             days prior to enrollment (with the exception of uncomplicated urinary tract infection
             or upper respiratory tract infection).

          8. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.

          9. Unstable coronary artery disease or myocardial infarction during preceding 6 months.

         10. Receiving any concomitant antitumor therapy.

         11. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary
             hypertension.

         12. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving
             the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with
             narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride,
             dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to
             receiving the first dose of ABI-009.

         13. Known Human Immunodeficiency Virus (HIV).

         14. Active Hepatitis B or Hepatitis C.

         15. Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks
             of trial enrollment

         16. Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis
             (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor
             neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome)

         17. Systemic immunosuppression, including HIV positive status with or without AIDS

         18. Skin rash (psoriasis, eczema) affecting > 25% body surface area

         19. Inflammatory bowel disease (Crohn's or ulcerative colitis)

         20. Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment

         21. Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal
             obstruction within 6 months of trial enrollment, which are known risk factors for
             bowel perforation

         22. Current, active or previous history of heavy alcohol abuse

         23. Pituitary endocrinopathy

         24. Adrenal insufficiency or excess
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Erlinda M Gordon, MD, 310-552-9999, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03190174

Organization ID

SOC-1701


Responsible Party

Sponsor

Study Sponsor

Sarcoma Oncology Research Center, LLC

Collaborators

 Aadi, LLC

Study Sponsor

Erlinda M Gordon, MD, Principal Investigator, Sarcoma Oncology Research Center


Verification Date

May 2021