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

  • End date
    Dec 11, 2024
  • participants needed
  • sponsor
    SOLTI Breast Cancer Research Group
Updated on 22 August 2021
measurable disease


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.


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.

Condition Anal Squamous Cell Carcinoma, HEPATIC NEOPLASM, carcinoma of the bladder, soft tissue sarcomas, Ovarian Serous Cystadenocarcinoma, Thyroid Cancer, Thyroid Adenoma, Thyroid Disorders, carcinoma of cervix, Skin Cancer, Carcinoma of Unknown Primary, Cholangiocarcinoma, skin cancer, Adenocarcinoma of Prostate, her2/neu-positive breast cancer, Small Cell Lung Cancer, Mesothelioma, Thyroid Disease, carcinoma of the cervix, liver cell carcinoma, stomach adenocarcinoma, MSI-H Colorectal Cancer, All Solid Tumors, head and neck cancer, bladder cancer, Other Histology, Cervical Intraepithelial Neoplasia, Esophageal Adenocarcinoma, Prostate Adenocarcinoma, Malignant Mesothelioma, Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma, Bladder Carcinoma, Sarcoma (Pediatric), carcinoma of the cervix uteri, anal carcinoma, Renal Cell Carcinoma, Squamous Esophageal Carcinoma, Squamous Cell Lung Cancer, Anal Cancer, sclc, Malignant Adenoma, small cell carcinoma of the lung, cervix cancer, Liver Cancer, cancer of the cervix, Bladder Cancer, Colorectal Adenocarcinoma, Metastatic Melanoma, Sarcoma, Connective and Soft Tissue Neoplasm, Renal Cell Cancer, Urothelial Cancer, Head and Neck Cancer, small cell carcinoma, HER2 Positive Breast Cancer, Squamous Cell Carcinoma of Head and Neck, Cervical Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Adenocarcinoma of the Prostate, Hormone Receptor Positive / HER2-negative Breast Cancer, sarcomas, clear cell renal cell carcinoma, Lung Adenocarcinoma EGFR-mutated/ ALK Traslocation, her2-positive breast cancer, Solid Tumors, Breast Cancer, carcinosarcoma of the uterus, adenocarcinoma of esophagus, Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Melanoma, HEPATOCELLULAR CARCINOMA, melanoma, Uterine Carcinosarcoma, Squamous Cell Carcinoma of Lung, Malignant Melanoma, Pancreatic Adenocarcinoma, thyroid carcinoma, Gastric Adenocarcinoma, Uveal Melanoma, cervical carcinoma, Thyroid disorder, Uterine Endometrial Carcinoma
Treatment spartalizumab
Clinical Study IdentifierNCT04802876
SponsorSOLTI Breast Cancer Research Group
Last Modified on22 August 2021


Yes No Not Sure

Inclusion Criteria

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
Life expectancy > 3 months as per investigator opinion
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
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 lesions
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
Have adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment
Patients could have received any number of previous treatments other than immune checkpoint inhibitors
Treatment-related toxicities (except alopecia) must Grade 1 at the time of allocation according to CTCAE version 5.0

Exclusion Criteria

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 medication
\. 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
\. 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 treatment
\. 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
\. Use of any live vaccines against infectious diseases within 4 weeks of
initiation of study treatment
\. 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
\. 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
\. 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
\. 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 treatment
\. Has severe hypersensitivity (Grade 3) to Spartalizumab and/or any of its
\. History of severe hypersensitivity reactions to other monoclonal
antibodies, which in the opinion of the investigator may pose an increased
risk of serious infusion reaction
\. 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
\. Has a history of (non-infectious) pneumonitis that required steroids or
has current pneumonitis
\. Has an active infection requiring systemic therapy
\. Has a known history of Human Immunodeficiency Virus (HIV)
\. 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) infection
\. Has a known history of active TBC (Bacillus Tuberculosis)
\. 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
\. Has known psychiatric or substance abuse disorders that would interfere
with cooperation with the requirements of the trial
\. 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
\. 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
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 contraception
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
Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject
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 contraception
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
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
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