Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PDR001, spartalizumab (PDR001)
Spartalizumab · 18 trials · 63 indications
An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any adverse event \[appearance of (or worsening of any pre-existing)\] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: fatal, life-threatening, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage.
Severity of AEs and SAEs will be measured according to the CTCAE v5.0
Proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type.
ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to BIRC radiological assessment by RECIST 1.1. CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Number of participants in each category (progression, death, censored) is reported in this record.
PFS is the time from the date of randomization to the date of event defined as the first documented confirmed progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on central review of tumor scan and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive disease is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.
Safety data.
Primary Outcome of phase Ib part
Primary Outcome of phase Ib part
Disease control rate (DCR: objective response + stable disease) at 12 weeks Primary Outcome of phase 2 part(defined by RECIST v1.1)
number of patients reporting dose limiting toxicity
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Frequency of patients requiring a dose interruption
Frequency of patients discontinuing treatment.
Frequency of patients requiring a dose reduction.
Incidence and severity of AEs and SAEs
The incidence of DLTs during the first two cycles of treatment with MBG453 in combination with PDR001 or PDR001 and/or MBG453 in combination with decitabine.
Incidence and severity of AEs and SAEs
A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Tolerability measured by the number of subjects who have interruptions of study treatment
Tolerability measured by the number of subjects who have reductions of study treatment
Tolerability measured by the dose intensity of study treatment
During the first two cycles Cycle = 28 days
Through study completion, an average of 6 months
Through study completion, an average of 6 months
Through study completion, an average of 6 months
Through study completion, an average of 6 months
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 2 cycles of treatment with capmatinib in combination with spartalizumab during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. The duration of one treatment cycle is 21 days.
Number of participants with at least one dose reduction of capmatinib and spartalizumab and number of participants with at least one dose interruption of capmatinib and spartalizumab. No dose modifications (i.e. dose reduction) were allowed for spartalizumab.
Dose intensity of capmatinib was calculated as actual cumulative dose in milligrams divided by duration of exposure in days.
Dose intensity of spartalizumab was calculated as actual cumulative dose in milligrams divided by duration of exposure in weeks and then multiplied by 3 weeks (3W).
Tumor response was based on local investigator assessment as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001. AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
DLT is defined as an adverse event (AE) or abnormal laboratory value of common terminology criteria for adverse events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with PDR001 during the dose escalation part of the study for which relationship to study treatment cannot be ruled out, with some exceptions.
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required. PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required. RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Feasibility of spartalizumab and canakinumab will be met if \> 85% of patients proceed to radical nephrectomy (12 of 14).
| Arm | Type | Description |
|---|---|---|
| sabatolimab + azacitidine | EXPERIMENTAL | Patients will take sabatolimab 800 mg i.v and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w or sabatolimab 400 mg i.v/q2w and azacitidine 75 mg/m2/d d1-7 s.c. or i.v./q4w. |
| sabatolimab + decitabine | EXPERIMENTAL | Patients will take Sabatolimab 400 mg i.v/q2w and decitabine 20 mg/m2/d d1-5 i.v. |
| sabatolimab + venetoclax + azacitidine | EXPERIMENTAL | Patients will take sabatolimab 200 mg i.v./q2w and venetoclax 400 mg p.o. d1-14/q4wk and azacitidine 75 mg/m2/d d1-7/q4w. |
| sabatolimab + spartalizumab + decitabine | EXPERIMENTAL | Patients will take sabatolimab 400 mg i.v./q2w and decitabine 20 mg/m2/d d1-5 i.v. and spartalizumab 100 mg i.v/q2w. |
| sabatolimab + HMA | EXPERIMENTAL | Patients will take sabatolimab 800 mg and azacitidine 75 mg/m2/d d1-7 or decitabine 20 mg/m2/d d1-5/ all q4w HMA means hypomethylating agents. Hypomethylating agents are azacitidine and decitabine. |
| sabatolimab | EXPERIMENTAL | Patients will take sabatolimab 800 mg i.v q4w. |
| Spartalizumab (PDR001) (Cohort-1 PD1-high) | EXPERIMENTAL | 400mg/intravenous every 28 days |
| Spartalizumab (PDR001) (Cohort-2 PD1-low) | EXPERIMENTAL | 400mg/intravenous every 28 days |
| Tislelizumab (Cohort-3 PD1-high) | EXPERIMENTAL | 300mg/intravenous every 28 days |
| Arm 1: LAG525 + PDR001 (randomized section) | EXPERIMENTAL | Participnats randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| Arm 2: INC280+PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks |
| Arm 3: ACZ885 + PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| Arm 4: LEE011 + PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks |
| Arm 1A: LAG525 + PDR001 (non-randomized section) | EXPERIMENTAL | LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| PDR001+LAG525 | EXPERIMENTAL | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001. |
| PDR001 | EXPERIMENTAL | Subjects with advanced or metastatic, well-differentiated, NET of pancreatic, GI, or thoracic origin or poorly-differentiated GEP-NEC, that have progressed on prior treatment were treated with 400mg PDR001 administered via intravenous infusion once every 4 weeks. |
| Spartalizumab 400 mg Q4W | EXPERIMENTAL | anti-PD1 humanized monoclonal antibody. Participants treated with spartalizumab who remained on spartalizumab |
| Chemotherapy | ACTIVE_COMPARATOR | commonly used chemotherapy as per investigator's choice |
| PDR001 plus Imatinib | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | Dose escalation of single agent CJM112 |
| Arm B | EXPERIMENTAL | Dose escalation of CJM112 in combination with a fixed dose of PDR001 |
| Arm C | EXPERIMENTAL | Dose escalation of LCL161 in combination with a fixed dose of PDR001 |
| Decitabine and PDR001 | EXPERIMENTAL | Decitabine in combination with PDR001 |
| Decitabine and MBG453 | EXPERIMENTAL | Decitabine in combination with MBG453 |
| Decitabine, PDR001 and MBG453 | EXPERIMENTAL | Decitabine in combination with PDR001 and MBG453 |
| MBG453 | EXPERIMENTAL | MBG453 alone |
| MBG453 and PDR001 | EXPERIMENTAL | MBG453 in combination with PDR001 |
| Azacitidine and MBG453 | EXPERIMENTAL | Azacitidine in combination with MBG453 |
| spartalizumab (PDR001) + regorafenib | EXPERIMENTAL | Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib. |
| PDR001 + Sorafenib | OTHER | PDR001 at 400 mg given intravenously every 4 weeks and sorafenib 400 mg taken orally once or twice per day (escalating doses) |
| CRC - PDR001 + LCL161 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| NSCLC - PDR001 + LCL161 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| TNBC - PDR001 + LCL161 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| CRC - PDR001+ Everolimus | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| NSCLC - PDR001+ Everolimus | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| TNBC - PDR001+ Everolimus | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| CRC - PDR001 + Panobinostat | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| NSCLC - PDR001 + Panobinostat | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| TNBC - PDR001 + Panobinostat | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| CRC - PDR001 + QBM076 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| TNBC - PDR001 + QBM076 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| NSCLC- PDR001 + QBM076 | EXPERIMENTAL | Enrollment to this combination arm is closed to further enrollment. |
| CRC - PDR001 + HDM201 | EXPERIMENTAL | Dose escalation completed, expansion arm. |
| RCC - PDR001 + HDM201 | EXPERIMENTAL | Dose escalation completed, expansion arm. |
| PDR + ACZ 100mg Q8W | EXPERIMENTAL | PDR + ACZ 100mg Q8W |
| PDR + ACZ 300mg Q8W | EXPERIMENTAL | PDR + ACZ 300mg Q8W |
| PDR + ACZ RDE TNBC | EXPERIMENTAL | PDR + ACZ Recommended Dose for Expansion (RDE) Triple Negative Breast Cancer (TNBC) |
| PDR + ACZ RDE NSCLC | EXPERIMENTAL | PDR + ACZ Recommended Dose for Expansion (RDE) Non-Small Cell Lung Cancer (NSCLC) |
| PDR + ACZ RDE CRC | EXPERIMENTAL | PDR + ACZ Recommended Dose for Expansion (RDE) Colorectal Cancer (CRC) |
| PDR + CJM 25mg Q4W | EXPERIMENTAL | PDR + CJM 25mg Q4W |
| PDR + CJM 75mg Q4W | EXPERIMENTAL | PDR + CJM 75mg Q4W |
| PDR + CJM 225mg Q4W | EXPERIMENTAL | PDR + CJM 225mg Q4W |
| PDR + CJM 450mg Q4W | EXPERIMENTAL | PDR + CJM 450mg Q4W |
| PDR + CJM 450mg Q2W | EXPERIMENTAL | PDR + CJM 450mg Q2W |
| PDR + CJM 900mg Q4W | EXPERIMENTAL | PDR + CJM 900mg Q4W |
| PDR + CJM 900mg Q2W | EXPERIMENTAL | PDR + CJM 900mg Q2W |
| PDR + CJM 1200mg Q4W | EXPERIMENTAL | PDR + CJM 1200mg Q4W |
| PDR + TMT 0.5mg QD | EXPERIMENTAL | PDR + TMT 0.5mg QD |
| PDR + TMT 1mg QD | EXPERIMENTAL | PDR + TMT 1mg QD |
| PDR + TMT 1mg QD, 3 Weeks on/1 Week off | EXPERIMENTAL | PDR + TMT 1mg QD, 3 Weeks on/1 Week off |
| PDR + TMT 1.5 mg QD, 2 Weeks on/2 Weeks off | EXPERIMENTAL | PDR + TMT 1.5 mg QD, 2 Weeks on/2 Weeks off |
| PDR + TMT 1.5 mg QD, 3 Weeks on/1 Week off | EXPERIMENTAL | PDR + TMT 1.5 mg QD, 3 Weeks on/1 Week off |
| PDR + EGF816 25mg QD | EXPERIMENTAL | PDR + EGF816 25mg QD |
| PDR + EGF816 50mg QD | EXPERIMENTAL | PDR + EGF816 50mg QD |
| s.a. ACZ RDE TNBC | EXPERIMENTAL | Single agent (s.a.) ACZ Recommended Dose for Expansion (RDE) Triple Negative Breast Cancer (TNBC) |
| s.a. ACZ RDE NSCLC | EXPERIMENTAL | Single agent (s.a.) ACZ Recommended Dose for Expansion (RDE) Non-Small Cell Lung Cancer (NSCLC) |
| s.a. ACZ RDE CRC | EXPERIMENTAL | Single agent (s.a.) ACZ Recommended Dose for Expansion (RDE) Colorectal Cancer (CRC) |
| Phase Ib: Capmatinib 200 mg BID + Spartalizumab 300 mg Q3W | EXPERIMENTAL | Capmatinib 200 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib |
| Phase Ib: Capmatinib 300 mg BID + Spartalizumab 300 mg Q3W | EXPERIMENTAL | Capmatinib 300 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib |
| Phase Ib: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W | EXPERIMENTAL | Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase Ib |
| Phase II: Capmatinib 400 mg BID + Spartalizumab 300 mg Q3W | EXPERIMENTAL | Capmatinib 400 mg administered orally on a continuous twice daily (BID) dosing schedule in combination with spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II |
| Phase II: Spartalizumab 300 mg Q3W | EXPERIMENTAL | Spartalizumab 300 mg administered intravenously once every 3 weeks (Q3W) in Phase II |
| patients with solid tumors | OTHER | Phase I Dose escalation cohorts |
| Selected tumor types | OTHER | Phase II expansion: Selected tumor types: melanoma, NSCLC, triple negative breast cancer, anaplastic thyroid cancer |
| Spartalizumab and Canakinumab | EXPERIMENTAL | Subjects with renal cell carcinoma will receive study treatment Q4 weeks x 2 doses prior to radical nephrectomy. |
| Name | Type | Description |
|---|---|---|
| decitabine | DRUG | Solution for intravenous infusion |
| spartalizumab | DRUG | Solution for intravenous infusion |
| sabatolimab | DRUG | Solution for intravenous infusion |
| azacitidine | DRUG | Solution for subcutaneous injection or intravenous infusion |
| venetoclax | DRUG | Tablet for oral administration |
| INQOVI (oral decitabine) | DRUG | Tablet for oral administration. HMA = azactidine or decitabine INQOVI = decitabine (oral) |
| Tislelizumab | DRUG | Tislelizumab 300mg will be given intravenously every 28 days |
| PDR001 | DRUG | 400 mg of PDR001 administered every 4 weeks intravenously |
| LAG525 | DRUG | 600 mg of LAG525 administered every 4 weeks intravenously |
| INC280 | DRUG | 400 mg of INC280 administered twice daily orally |
| ACZ885 | DRUG | 200 mg of ACZ885 administered every 4 weeks subcutaneosuly |
| LEE011 | DRUG | 600 mg of LEE011 orally taken once daily on Days 1-21 of a 28-day cycle |
| Investigator choice of chemotherapy | DRUG | Commonly used chemotherapy as per investigator's choice. The dose and route of administration was the one described in each drug's label. |
| PDR001, Imatinib | DRUG | -Phase Ib part : The standard 3+3 dose escalation scheme will be applied. DLTs will be evaluated during the first cycle (4 weeks). PDR001 400mg, every 4 weeks, IV Imatinib dose level -1 : 200mg, PO, QD Imatinib dose level 1 : 300mg, PO, QD Imatinib dose level 2 : 400mg, PO, QD -Phase II part * Recommended dose defined in phase Ib part will be tested |
| CJM112 | DRUG | Anti-IL-17A antibody |
| LCL161 | DRUG | Oral small molecule SMAC-mimetic |
| MBG453 | DRUG | MBG453 is a high-affinity, humanized anti-TIM-3 IgG4 monoclonal antibody which blocks the binding of TIM-3 to phosphatidylserine (PtdSer). |
| spartalizumab (PDR001) | DRUG | 100 mg lyophilisate in vial received 400 mg every 4 weeks |
| regorafenib | DRUG | 120 mg once daily first 21 days of each 28-day cycle (=4 weeks) |
| Sorafenib | DRUG | Sorafenib is formulated as a tablet. |
| Everolimus | DRUG | - |
| Panobinostat | DRUG | - |
| QBM076 | DRUG | - |
| HDM201 | DRUG | - |
| TMT212 | DRUG | Tablets |
| EGF816 | DRUG | Tablets |
| Capmatinib | DRUG | Capmatinib administered orally as a tablet on a continuous twice daily (BID) dosing schedule |
| Canakinumab | DRUG | Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion |
Inclusion Criteria: 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines ...
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Spartalizumab is an investigational monoclonal antibody being studied in oncology for advanced solid tumors and blood cancers. Its research indications include advanced hepatocellular carcinoma, renal cell carcinoma, colorectal cancer, non-small cell lung carcinoma, triple negative breast cancer, and other advanced malignancies. It is not approved for commercial use and remains in clinical development.
Spartalizumab targets PDCD1, also known as PD-1, a checkpoint protein on immune cells. It acts as an antagonist, blocking the PD-1 pathway to help restore antitumor immune responses. This mechanism is being evaluated across multiple cancer types in clinical trials.
Spartalizumab is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsors the clinical trials evaluating the drug in advanced solid tumors and other malignancies.
Spartalizumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program includes studies in advanced solid tumors and combination therapies.
Spartalizumab is being studied in trials including NCT05201066, a Phase 2 rollover study in myelodysplastic syndromes and chronic myelomonocytic leukemia; NCT04802876, a Phase 2 study in PD1-high mRNA expressing tumors; NCT04058756, a Phase 1 rollover study in advanced solid tumors; and NCT04028245, an early Phase 1 study in localized clear cell renal cell carcinoma.
Yes, spartalizumab is also known as PDR001. Both names refer to the same investigational monoclonal antibody developed by Novartis. The alternative name PDR001 may appear in scientific literature and clinical trial records.