Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

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Brief Title

Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma

Official Title

Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (the NIPU-study)

Brief Summary

      The objective of the study is to induce a meaningful progression-free survival benefit in
      patients with Malign Pleural Mesothelioma (MPM) after progression on first line standard
      platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1
      vaccine.
    

Detailed Description

      Several studies have investigated the use of checkpoint inhibition in Malign Pleural
      Mesothelioma (MPM). Most of them are small studies investigating the efficacy of single-agent
      immunotherapy in few patients. Given that the combination of anti-PD-1 or anti-PD-L1 therapy
      with CTLA-4 has been shown in other cancers to enhance treatment effect, combined checkpoint
      inhibitor treatment has also been investigated in patients with MPM. Although these results
      are encouraging, the response rates seen are moderate compared to what has been documented
      for the combination of checkpoint inhibitors in other cancer indications. An approach to
      further enhance the PFS and response rate in MPM may be to use a vaccine aiming to activate
      an immune response directed against tumor-related antigens, and to combine the vaccine with
      checkpoint inhibitors. The proposed study will evaluate the use of the therapeutic cancer
      vaccine UV1 in combination with nivolumab and ipilimumab after progression on standard
      first-line chemotherapy in patients with malignant pleural mesothelioma.

      The objective of the study is to induce a meaningful progression-free survival benefit in
      patients with MPM after progression on first line standard platinum doublet chemotherapy, by
      treating with nivolumab and ipilimumab with or without UV1.

      The primary end-point (PFS) is expected to be analyzed in 2022.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Evaluation of efficacy of ipilimumab and nivolumab With or without UV1 vaccine in patients With inoperable malignant pleural mesothelioma progressing after first-line platinum-based chemotherapy.

Secondary Outcome

 Response evaluation

Condition

Cancer

Intervention

UV1 vaccine + leukine

Study Arms / Comparison Groups

 Arm A
Description:  Ipilimumab and nivolumab + UV1

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

Biological

Estimated Enrollment

118

Start Date

May 4, 2020

Completion Date

March 15, 2027

Primary Completion Date

March 15, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically and/or cytologically confirmed malignant pleural mesothelioma.

          -  Unresectable disease

          -  Measurable disease, defined as at least 1 lesion (measurable) that can be accurately
             assessed at baseline by computed tomography (CT) or magnetic resonance imaging (MRI)
             and is suitable for repeated assessment (modified RECIST).

          -  Available unstained archived tumor tissue sample in sufficient quantity to allow for
             analyses. At least fifteen unstained slides or a tumor block (preferred). NOTE: A fine
             needle aspiration sample is not sufficient to make the patient eligible for
             enrollment. Given the complexity of mesothelioma pathological diagnosis , it is
             expected that they will have a core needle biopsy or surgical tumor biopsy as part of
             their initial diagnostic work up.

          -  Age ≥ 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

          -  Willing to provide archived tumor tissue and blood samples for research.

          -  Adequate organ function as defined below

               1. Haemoglobin ≥ 9.0 g/dL

               2. Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)

               3. Platelet count ≥100 (or 75) x 109/L (>75,000 per mm3)

               4. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).

               5. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver
                  metastases are present, in which case it must be ≤5x ULN

               6. Measured creatinine clearance (CL)

                    1. >40 mL/min

                    2. Calculated creatinine CL>40 mL/min (Cockcroft-Gault formula)

                    3. 24-hour urinecollection for determination of CL

          -  Males: Creatinine CL (mL/min) =Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)

          -  Females:Creatinine CL (mL/min)=Weight (kg) x (140 - Age)x0.85 72 x serum creatinine
             (mg/dL)

          -  Previously treated with at least one line of platinum -pemetrexed

        Exclusion Criteria:

          -  Disease suitable for curative surgery

          -  Previous treatment with a PD-1 or PD-L1 inhibitor, including nivolumab or any other
             agent targeting immune checkpoints.

          -  Non-pleural mesothelioma e.g. mesothelioma arising in peritoneum, tunica vaginalis or
             any serosal surface other than the pleura.

          -  Active second malignancy other than non-melanoma skin cancer or cervical carcinoma in
             situ.

          -  Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive
             of but not limited to surgery, radiation and/or corticosteroids (prednisone >10 mg or
             equivalent). Surgery, radiation and/or corticosteroids (any dose >10 mg prednisone
             equivalent) must have been completed ≥ 2 weeks prior to registration.

          -  Uncontrolled seizures.

          -  Current or prior use of immunosuppressive medication within 28 days before the first
             dose of nivolumab, with the exceptions of intranasal and inhaled corticosteroids or
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of
             prednisone, or an equivalent corticosteroid. Standard steroid premedication given
             prior to chemotherapy or as prophylaxis for imaging contrast allergy should not be
             counted for this criterion.

          -  Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease, diverticulitis with the exception of diverticulosis,
             celiac disease, irritable bowel disease; Wegner syndrome) within the past 2 years.
             Subjects with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic
             treatment (within the past 3 years) are not excluded.

          -  History of primary immunodeficiency.

          -  History of allogeneic organ transplant.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
             bleeding diatheses including any subject known to have psychiatric illness/social
             situations that would limit compliance with study requirements or compromise the
             ability of the subject to give written informed consent.

          -  Active infection including tuberculosis (clinical evaluation including: physical
             examination findings, radiographic findings, positive PPD test, etc.), hepatitis B
             (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human
             immunodeficiency virus (positive HIV 1/2 antibodies as defined by a positive ELISA
             test). Patients with a past or resolved HBV infection (defined as the presence of
             hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients
             positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction
             is negative for HCV RNA. HIV testing is not required in the absence of clinical
             suspicion.

          -  Known history of leptomeningeal carcinomatosis.

          -  Pregnant or lactating women

          -  Live attenuated vaccination within 30 days prior to study entry or within 30 days of
             receiving nivolumab.

          -  Any condition that, in the opinion of the investigator, would interfere with the
             evaluation of study treatment or interpretation of patient safety or study results.

          -  History of allergy or hypersensitivity to any of the active substances or excipients
             in the study drug.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Åslaug Helland, Prof, MD, +47 22934000, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04300244

Organization ID

CA209-7H4 NIPU


Responsible Party

Sponsor-Investigator

Study Sponsor

Åslaug Helland

Collaborators

 Oslo University Hospital

Study Sponsor

Åslaug Helland, Prof, MD, Principal Investigator, Oslo University Hospital


Verification Date

June 2020