Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors

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Brief Title

Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors

Official Title

Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Defined by a Single and Pre-specified Cutoff

Brief Summary

      This is an open-label, single arm, non-randomized, multicenter phase II study to evaluate the
      efficacy of spartalizumab in monotherapy in metastatic patients with Programmed Death-1
      (PD1)-high-expressing tumors.

Detailed Description

      A molecular pre-screening will be performed to know PD1 messenger RNA (mRNA) expression
      levels on a tumor sample using the nCounter-based technology. This will be centrally
      performed at Hospital Clinic of Barcelona. If the tumor is PD1-high (Cohort 1), as defined by
      the pre-specified cutoff, patients (a total of 111) will receive spartalizumab 400 mg every
      four weeks. A cohort of 30 patients with PD1-low advanced solid tumors where the efficacy of
      PD1 inhibitors has been previously established (i.e. with a FDA or EMA monotherapy indication
      approved) will also be recruited (cohort 2).

      One of the aims of the study is to show the value of the biomarker independently of the tumor
      histology. Thus, a wide variety of cancer-types (30 different types) will be represented.

Study Phase

Phase 2

Study Type


Primary Outcome

Overall Response rate (ORR)

Secondary Outcome

 Clinical Benefit Rate (CBR) in patients with high mRNA PD1 expressing tumors (Cohort 1)


MSI-H Colorectal Cancer



Study Arms / Comparison Groups

 Spartalizumab (PDR001)
Description:  400mg/intravenous every 28 days


* 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


Estimated Enrollment


Start Date

April 12, 2021

Completion Date

December 11, 2024

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Male/female participants who are at least 18 years of age on the day of signing
             informed consent with histologically confirmed diagnosis of PD1 mRNA high-expression
             (cohort 1) or PD1 mRNA low-expression (cohort 2) determined on the tumor sample will
             be enrolled in this study. Enrollment of patients > 75 years of age is allowed after
             consultation and approval of the study medical monitor.

          2. Life expectancy > 3 months as per investigator opinion.

          3. The participant (or legally acceptable representative if applicable) provides written
             specific informed consent for the remaining screening tests and study procedures
             before inclusion in the trial.

          4. Have measurable disease based on RECIST 1.1. Lesions situated in a previously
             irradiated area are considered measurable if progression has been demonstrated in such

          5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
             Evaluation of ECOG is to be performed within 10 days prior to the date of allocation.

          6. Have adequate organ function. Specimens must be collected within 10 days prior to the
             start of study treatment.

          7. Patients could have received any number of previous treatments other than immune
             checkpoint inhibitors.

          8. Treatment-related toxicities (except alopecia) must ≤ Grade 1 at the time of
             allocation according to CTCAE version 5.0.

        Exclusion Criteria:

          1. A Women of childbearing potential who has a positive urine pregnancy test within 72
             hours prior to allocation. If the urine test is positive or cannot be confirmed as
             negative, a serum pregnancy test will be required.

             Note: in the event that 72 hours have elapsed between the screening pregnancy test and
             the first dose of study treatment, another pregnancy test (urine or serum) must be
             performed and must be negative in order for subject to start receiving study

          2. Has received prior therapy with an anti-PD1, anti-PDL1, or anti-PDL2 agent or with an
             agent directed to another stimulatory or co-inhibitory T-cell receptor.

          3. Has received prior systemic anti-cancer therapy, including investigational agents
             within 2 weeks. Medical Monitor could consider shorter interval for kinase inhibitors
             or other short half-life drugs prior to allocation.

             Note: Participants must have recovered from all AEs due to previous therapies to
             ≤Grade 1 or baseline according to CTCAE version 5.0 (except alopecia). Participants
             with ≤Grade 2 neuropathy may be eligible.

             Note: If participant received major surgery, they must have recovered adequately from
             the toxicity and/or complications from the intervention prior to starting study

          4. Has received prior radiotherapy within 2 weeks of start of study treatment.
             Participants must have recovered from all radiation-related toxicities, not require
             corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted
             for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.

          5. Use of any live vaccines against infectious diseases within 4 weeks of initiation of
             study treatment.

          6. Is currently participating in or has participated in a study of an investigational
             agent or has used an investigational device within 2 weeks prior to the first dose of
             study treatment.

             Note: Participants who have entered the follow-up phase of an investigational study
             may participate as long as it has been 2 weeks after the last dose of the previous
             investigational agent.

          7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
             (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
             immunosuppressive therapy within 7 days prior to the first dose of study drug.

          8. Has a known additional malignancy that is progressing or has required active treatment
             within the past 3 years.

             Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of
             the skin or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that
             have undergone potentially curative therapy are not excluded.

          9. Patients with thymoma are not eligible. Patients with active CNS metastases and/or
             carcinomatous meningitis are not eligible. Subjects with up to three cerebral
             metastases are eligible, if all lesions are stable and have been definitively treated
             with stereotactic radiation therapy, surgery or gamma knife therapy with no evidence
             of disease 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

         10. Has severe hypersensitivity (≥Grade 3) to Spartalizumab and/or any of its excipients.

         11. History of severe hypersensitivity reactions to other monoclonal antibodies, which in
             the opinion of the investigator may pose an increased risk of serious infusion

         12. Has active autoimmune disease that has required systemic treatment in the past 2 years
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
             drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
             form of systemic treatment.

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

         14. Has an active infection requiring systemic therapy.

         15. Has a known history of Human Immunodeficiency Virus (HIV).

         16. 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)

         17. Has a known history of active TBC (Bacillus Tuberculosis).

         18. Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the study, interfere with the subject's
             participation for the full duration of the study, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator.

         19. Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial.

         20. Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 150 days
             after the last dose of trial treatment.

         21. Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective methods of contraception
             during dosing and for 150-days after stopping treatment with spartalizumab. Highly
             effective contraception methods include:

               1. Total abstinence (when this is in line with the preferred and usual lifestyle of
                  the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are not acceptable methods of

               2. Female sterilization (have had surgical bilateral oophorectomy with or without
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks before
                  taking study treatment. In case of oophorectomy alone, only when the reproductive
                  status of the woman has been confirmed by follow up hormone level assessment.

               3. Male sterilization (at least 6 months prior to screening). The vasectomized male
                  partner should be the sole partner for that subject.

               4. Placement of a non-hormonal intrauterine device (IUD) or intrauterine system
                  (IUS) with a documented failure rate of less than 1% per year.


               -  Double-barrier contraception: condom and occlusive cap (diaphragm or
                  cervical/vault caps) with a vaginal spermicidal agent
                  (foam/gel/cream/suppository) are not considered highly effective methods of

               -  Women are considered post-menopausal and not of child bearing potential if they
                  have had 12 months of natural (spontaneous) amenorrhea with an appropriate
                  clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have
                  had surgical bilateral oophorectomy (with or without hysterectomy), total
                  hysterectomy, or tubal ligation at least six weeks ago. In the case of
                  oophorectomy alone, only when the reproductive status of the woman has been
                  confirmed by follow up hormone level assessment is she considered not of child
                  bearing potential.

         22. Sexually active males, unless they use a condom during intercourse while on treatment
             and for 150 days after stopping treatment with spartalizumab should not father a child
             in this period. A condom is required to be used by vasectomized men as well during
             intercourse in order to prevent delivery of the drug via semen.




18 Years - N/A

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

SOLTI Breast Cancer Research Group



Study Sponsor

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Verification Date

October 2022