Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AIM ImmunoTech Inc. | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a phase II single arm efficacy/safety trial that will evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP rintatolimod (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer (OC).
Patients will receive a total of six treatment cycles, at 3-week intervals. The study will use an IP neoadjuvant approach (IP chemoimmunotherapy of cisplatin with IP rintatolimod and IV infusion of pembrolizumab), followed by interval cytoreduction (usually laparoscopically) of residual tumor. Cytoreduction will occur approximately 4 weeks after the fourth treatment cycle. Post-surgery the investigators will consolidate with 2 additional courses of same chemo-immunotherapy regimen. Catheter will be removed 12 weeks after the last treatment. All surgical procedures, if done laparoscopically, are outpatient and will yield up to three serial biopsies of the tumor sites: 1) at catheter placement; 2) at interval cytoreduction which consists of removal of any visible tumor sites and the site biopsied initially whether tumor is present or not; 3) at catheter removal, when site of first tumor biopsy will be re-biopsied for pathologic response.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cisplatin + rintatolimod + pembrolizumab | Experimental | Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rintatolimod | Drug | 200 mg by IP administration over 1-2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a > 30% decrease in size of lesion from baseline. | At 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DLTs Related to Treatment | Number of patients who experience Adverse Events per CTCAE v5.0 related to study treatment, including any death not clearly due to disease or extraneous causes, AE leading to a dose delay of greater than 14 days in initiation of cycle 2, a DLT occurring during Cycle 1 of treatment: Grade ≥ 3 renal toxicity, diarrhea, skin toxicity, injection site reactions, anaphylaxis, hematologic toxicities lasting more than 48 hours (including neutropenia), non-hematologic toxicities, neurological symptoms, thrombocytopenia and hemorrhage, liver function test increase; Grade ≥ 2 or greater bronchospasm, allergic reaction or generalized urticaria, autoimmune reaction, pneumonitis; Fever > 41°C, uncontrolled for over 4 hours in the absence of a medical cause Evaluation of liver toxicity per Hy's Law: Drug causes hepatocellular injury (higher incidence of 3-fold or greater elevations above the ULN of ALT or AST); Total Bilirubin>2xULN (without initial cholestasis (elevated serum alkaline phosphatase) |
| Measure | Description | Time Frame |
|---|---|---|
| NK Cells | at baseline (pre-treatment) and at 12 weeks (after the start of treatment) | |
| Grandzyme B | at baseline (pre-treatment) and at 12 weeks (after the start of treatment) | |
Inclusion Criteria :
Patients must be at least 18 years of age on the day of signing informed consent.
Patients must have first or second peritoneal recurrence of epithelial adenocarcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin:
Patients must have completed prior platinum-based therapy. Response can be complete or partial if it otherwise meets platinum sensitive criteria, see below.
Patients must be platinum-sensitive, defined as having a progression free interval (PFI) of more than 6 months (180 days) from any platinum therapy. Patients are allowed to have had other lines of therapy since last platinum if PFI after platinum therapy meets platinum sensitive criteria.
Patients must have measurable disease in the peritoneal cavity, measurable per RECIST 1.1 criteria:
Patients must be a reasonable candidate for laparoscopy and IP platinum regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity or bowel obstruction.
Patients of childbearing potential must:
Patients must agree to the protocol designated clinical monitoring to receive the study regimens.
The participant provides written informed consent for the trial.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 28 days prior to the date of allocation/randomization.
Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 28days prior to the start of study treatment.
Exclusion Criteria :
A WOCBP who has a positive urine pregnancy test within 72 hours prior to infusion of treatment regimen (see Appendix 3). 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-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
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.
Patients with previous pelvic radiation therapy.
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 (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
o Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 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.
Patients with tumors of low malignant potential, except ovarian pseudomyxomas, or with no peritoneal disease.
Concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non- melanomatous skin cancer or curatively resected cervical cancer or per physician discretion that the previous cancer was adequately treated with curative intent and unlikely to recur (the study PI must concur with this determination).
Has 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.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has a known allergy to cisplatin chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions.
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). Note: No HIV testing is required unless mandated by local health authority.
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 qualitative is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
Has a known history of active TB (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 within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Ovarian cancer is limited to the female population.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Edwards, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin + Rintatolimod + Pembrolizumab | Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m^2 solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin + Rintatolimod + Pembrolizumab | Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m^2 solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a > 30% decrease in size of lesion from baseline. | Treated patients who were evaluable for radiologic response. | Posted | Number | 95% Confidence Interval | percentage of patients | At 13 weeks |
|
Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin + Rintatolimod + Pembrolizumab | Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m^2 solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | BLOOD AND LYMPHATIC SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stadterman, MPH, CCRP | UPMC Hillman Cancer Center | 4126475554 | stadtermanbm@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2021 | Jun 2, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C047490 | poly(I).poly(c12,U) |
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab | Drug | 200 mg will be administered as a 30 minute IV infusion |
|
|
| Cisplatin | Drug | 50mg/m^2 solution |
|
|
| At baseline (pre-treatment) and at 12 weeks (after the start of treatment) |
| Progression-Free Survival (PFS) | The length of time during and after study treatment that a patient does not experience worsening disease. Per RECIST 1.1 or dies from any cause. Progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions. | up to 4 years |
| Time To Disease Progression | The length of time during and after study treatment that a patient remains alive without worsening disease. Per RECIST 1.1, progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions. | up to 4 years |
| Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD8 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 1 Day 3 |
| Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 1 |
| Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | At treatment Cycle 4 Day 3 |
| Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 1 |
| Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 1 Day 3 |
| Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 1 |
| Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | At treatment Cycle 4 Day 3 |
| Overall Survival (OS) | Up to 3 years |
| CD4 Tbet |
| at baseline (pre-treatment) and at 12 weeks (after the start of treatment) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Disease.Site.Diagnosis | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | DLTs Related to Treatment | Number of patients who experience Adverse Events per CTCAE v5.0 related to study treatment, including any death not clearly due to disease or extraneous causes, AE leading to a dose delay of greater than 14 days in initiation of cycle 2, a DLT occurring during Cycle 1 of treatment: Grade ≥ 3 renal toxicity, diarrhea, skin toxicity, injection site reactions, anaphylaxis, hematologic toxicities lasting more than 48 hours (including neutropenia), non-hematologic toxicities, neurological symptoms, thrombocytopenia and hemorrhage, liver function test increase; Grade ≥ 2 or greater bronchospasm, allergic reaction or generalized urticaria, autoimmune reaction, pneumonitis; Fever > 41°C, uncontrolled for over 4 hours in the absence of a medical cause Evaluation of liver toxicity per Hy's Law: Drug causes hepatocellular injury (higher incidence of 3-fold or greater elevations above the ULN of ALT or AST); Total Bilirubin>2xULN (without initial cholestasis (elevated serum alkaline phosphatase) | Treated patients monitored for DLTs. | Posted | Number | patients | At baseline (pre-treatment) and at 12 weeks (after the start of treatment) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | The length of time during and after study treatment that a patient does not experience worsening disease. Per RECIST 1.1 or dies from any cause. Progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions. | Not Posted | up to 4 years | Participants |
| Secondary | Time To Disease Progression | The length of time during and after study treatment that a patient remains alive without worsening disease. Per RECIST 1.1, progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions. | Not Posted | up to 4 years | Participants |
| Secondary | Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD45 Cells | Within-patient mean change in percent of total number of CD45 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD45 Cells | Mean percent of total CD45 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD3 Cells | Within-patient mean change in percent of total number of CD3 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD3 Cells | Mean percent of total CD3 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD4 Cells | Within-patient mean change in percent of total number of CD4 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD4 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD8 Cells | Within-patient mean change in percent of total number of CD8 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD8 Cells | Mean percent of total CD4 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD8 Cells | Mean percent of total CD8 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Median | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Median | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD14 Cells | Within-patient mean change in percent of total number of CD14 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Median | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD14 Cells | Mean percent of total CD14 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD19 Cells | Within-patient mean change in percent of total number of CD19 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD19 Cells | Mean percent of total CD19 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Change in CD56 Cells | Within-patient mean change in percent of total number of CD56 cells present in tumor tissue and peritoneal fluid from treatment Cycle 1 Day 1. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 1 |
|
|
|
| Secondary | Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 1 Day 3 |
|
|
|
| Secondary | Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 1 |
|
|
|
| Secondary | Percent of CD56 Cells | Mean percent of total CD56 cells present in tumor tissue and peritoneal fluid from treatment. | Treated patients who provided analyzable samples. | Posted | Mean | Standard Deviation | percentage of cells | At treatment Cycle 4 Day 3 |
|
|
|
| Secondary | Overall Survival (OS) | Not Posted | Jan 2027 | Up to 3 years | Participants |
| Other Pre-specified | NK Cells | Not Posted | at baseline (pre-treatment) and at 12 weeks (after the start of treatment) | Participants |
| Other Pre-specified | Grandzyme B | Not Posted | at baseline (pre-treatment) and at 12 weeks (after the start of treatment) | Participants |
| Other Pre-specified | CD4 Tbet | Not Posted | at baseline (pre-treatment) and at 12 weeks (after the start of treatment) | Participants |
| 12 |
| 24 |
| 9 |
| 24 |
| 24 |
| 24 |
| Small intestinal perforation | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Small intestinal obstruction | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Obstruction gastric | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal pain | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Fever | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Device related infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Hyponatremia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypokalemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hyperglycemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Erythema multiforme | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Failure to thrive | SOCIAL CIRCUMSTANCES | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | VASCULAR DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | BLOOD AND LYMPHATIC SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Sinus tachycardia | CARDIAC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Sinus bradycardia | CARDIAC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Palpitations | CARDIAC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Vertigo | EAR AND LABYRINTH DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Tinnitus | EAR AND LABYRINTH DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Adrenal insufficiency | ENDOCRINE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Watering eyes | EYE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Eye pain | EYE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Blurred vision | EYE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Vomiting | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Small intestinal perforation | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Small intestinal obstruction | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Oral dysesthesia | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Obstruction gastric | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Gastrointestinal pain | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Bloody stools | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dysphagia | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dyspepsia | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dry mouth | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Bloating | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Ascites | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal pain | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal distension | GASTROINTESTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Pain | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Infusion site extravasation | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Flu like symptoms | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Fever | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Fatigue | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Edema limbs | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Chills | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | CTCAE (5.0) | Systematic Assessment |
|
| Allergic reaction | IMMUNE SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Vaginal infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Urinary tract infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Upper respiratory infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Skin infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Sepsis | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Device related infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Bacteremia | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal infection | INFECTIONS AND INFESTATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Infusion related reaction | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Fall | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Bruising | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | CTCAE (5.0) | Systematic Assessment |
|
| White blood cell decreased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Weight loss | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Platelet count decreased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Neutrophil count decreased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| increased BUN | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Creatinine increased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | INVESTIGATIONS | CTCAE (5.0) | Systematic Assessment |
|
| Hypophosphatemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hyponatremia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypomagnesemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypokalemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypoglycemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypocalcemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypoalbuminemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hyperuricemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hyperglycemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypercalcemia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dehydration | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | METABOLISM AND NUTRITION DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Myalgia | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Generalized muscle weakness | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Arthralgia | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Tremor | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Syncope | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Lethargy | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Headache | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dysgeusia | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dizziness | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Akathisia | NERVOUS SYSTEM DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Claustrophobic | PSYCHIATRIC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Insomnia | PSYCHIATRIC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Confusion | PSYCHIATRIC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Anxiety | PSYCHIATRIC DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Urinary incontinence | RENAL AND URINARY DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Urinary frequency | RENAL AND URINARY DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Proteinuria | RENAL AND URINARY DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hematuria | RENAL AND URINARY DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Chronic kidney disease | RENAL AND URINARY DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Pelvic pain | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Rhinorrhea | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Postnasal drip | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Nasal congestion | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hiccups | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dyspnea | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Cough | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Skin redness/ irritation | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| RUQ Redness/ Irritation | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Dermatologic Toxicity | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Cellulitus | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Rash maculo-papular | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Rash acneiform | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Pruritus | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hyperhidrosis | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Erythema multiforme | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Bullous dermatitis | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Alopecia | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Failure to thrive | SOCIAL CIRCUMSTANCES | CTCAE (5.0) | Systematic Assessment |
|
| Thromboembolic event | VASCULAR DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypotension | VASCULAR DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | VASCULAR DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
| Hematoma | VASCULAR DISORDERS | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided