Metastatic Pancreatic AdenocarcinomaPhase 1/2NCT04191421
Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
A Phase 1/2 study testing Siltuximab and Spartalizumab in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Emory University at 3 sites in United States.
Trial summary
This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
- What is being tested?
- Siltuximab and Spartalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2020to 5 Apr 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytological or histologic diagnosis and metastatic pancreatic adenocarcinoma disease that has failed at least one standard regimen such as gemcitabine nab-paclitaxel or folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX).
- Patient must meet the following laboratory values at the screening visit:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelets ≥ 75 x 109/L
- Hemoglobin (Hgb) ≥ 9 g/dL
- Serum creatinine < 1.5 mg/dL OR Creatinine Clearance ≥ 45 mL/min using Cockcroft-Gault formula
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- Total bilirubin ≤ 1.5 x ULN
- Aspartate transaminase (AST) ≤ 2.5 x ULN, except for patients with liver metastasis, who may only be included if AST ≤ 5.0 x upper limit of normal (ULN)
- Alanine transaminase (ALT) ≤ 2.5 x ULN, except for patients with liver metastasis, who may only be included if ALT ≤ 5.0 x ULN
- Presence of measurable disease by RECIST criteria
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Written informed consent must be obtained prior to any screening procedures.
- Normal ECG defined as the following:
- Resting heart rate 50-90 bpm
- QT corrected for HR using Fridericia's method (QTcF) at screening < 450 ms (male patients), < 460 ms (female patients)
- Before enrollment, a woman must be either:
- Not of childbearing potential: postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
- Of childbearing potential and practicing (during the study and for 150 days after receiving the last dose of study agent) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject)
- Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.
- A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening.
- During the study and for 150 days after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction.
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing and able to adhere to the prohibitions and restrictions specified in this protocol. Informed consent must be obtained before performing any study specific procedures.
Who cannot join
- Prior exposure to agents targeting programmed cell death protein-1 (PD-1), PD-L1, IL-6 or the IL-6 receptor. Prior chemotherapy is allowed as long as adequate washout period of ≥ 4 weeks.
- Any untreated central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks.
- Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted).
- Allogenic bone marrow or solid organ transplant.
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- 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.
- Known history or current interstitial lung disease or non-infectious pneumonitis.
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.
- Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity.
- Clinically significant ongoing infection.
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment (whichever is longer) or is currently enrolled in the treatment stage of an investigational study.
- A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 150 days after the last dose of study agent.
- Had hospitalization for infection or major surgery (eg, requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate.
- History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
- Recent myocardial infarction (within last 6 months)
- Uncontrolled congestive heart failure
- Unstable angina (within last 6 months)
- Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block (AV) block without a pacemaker)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer
This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the ability of tumors cells to grow and spread.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the recommended phase II dose for the combination of spartalizumab and siltuximab.
SECONDARY OBJECTIVES:
- Define the toxicity profile of the combination of the recommended phase II dose of spartalizumab and siltuximab.
II. Evaluate the activity of the combination of spartalizumab and siltuximab in previously treated patients with pancreatic cancer.
EXPLORATORY OBJECTIVE:
- Evaluate the effect of the combination on the immune profile in the serum and in tumor biopsies.
OUTLINE: This is a dose-escalation study of siltuximab.
Participants receive spartalizumab intravenously (IV) over 30 minutes on day 1 and siltuximab IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30, 60, 90, 120, and 150 days, then every 12 weeks thereafter.
- Being tested
- Siltuximab, Spartalizumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiltuximabBiological
Also called Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, Sylvant
Given IV
SpartalizumabBiological
Also called PDR001
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment spartalizumab and siltuximab Phase I dose level 1 | Experimental | Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: Siltuximab; Biological: Spartalizumab |
| Treatment spartalizumab and siltuximab Phase I level 2 | Experimental | Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: Siltuximab; Biological: Spartalizumab |
| Treatment spartalizumab and siltuximab phase I level 2a | Experimental | Arm 3 (Phase I dose level 2a) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 9 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: Siltuximab; Biological: Spartalizumab |
| Treatment spartalizumab and siltuximab phase II | Experimental | Arm 4 (Phase II ) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab at dose determined in Arm 1 to 3 IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: Siltuximab; Biological: Spartalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab
Maximal tolerated dose (MTD )is defined as the dose at which less than one-third of the subjects experience a dose-limiting toxicity (DLT) in the first 6 weeks of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as definitely at least possibly related to study treatment treatment related that occurs within the first 6 weeks. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Measured: Up to 6 weeks from study start
Secondary outcomes (4)
Overall Response Rate (ORR)
Overall response rate is defined as complete response (CR) + partial response (PR) in participants treated with siltuximab and spartalizumab and will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 2 years from study start
Response Duration
Will be assessed by RECIST 1.1.
Measured: From treatment start until progression or death, assessed up to 2 years
Progression-free Survival
Will be assessed by RECIST 1.1.
Measured: From treatment start until progression or death, assessed up to 2 years
Overall Survival Time
Will be assessed by RECIST 1.1.
Measured: From treatment start until progression or death, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start17 Jan 2020
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arm 1- (Phase I dose level 1)- Siltuximab 6 mg/Kg every 3 weeks and Spartalizumab 300mg every 3 weeks Arm 2- (Phase I dose level 2)- Siltuximab 11 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 3 - (Phase I doe level 2a)- Siltuximab 9 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 4- (Phase II)- Siltuximab RP2D determined in Arms 1 to 3 and spartalizumab 300 mg every 3weeks
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, EUSA Pharma, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Olatunji Alese, Emory University
- Investigators
- Olatunji Alese, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191421
- Sponsor's protocol ID
- IRB00105616
- Other IDs
- NCI-2018-01793, Winship4463-18, P30CA138292
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2019
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04191421
- Acronym / sponsor ID
- IRB00105616
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Novartis, EUSA Pharma, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the ability of tumors cells to grow and spread.
Detailed description
PRIMARY OBJECTIVE:
- Determine the recommended phase II dose for the combination of spartalizumab and siltuximab.
SECONDARY OBJECTIVES:
- Define the toxicity profile of the combination of the recommended phase II dose of spartalizumab and siltuximab.
II. Evaluate the activity of the combination of spartalizumab and siltuximab in previously treated patients with pancreatic cancer.
EXPLORATORY OBJECTIVE:
- Evaluate the effect of the combination on the immune profile in the serum and in tumor biopsies.
OUTLINE: This is a dose-escalation study of siltuximab.
Participants receive spartalizumab intravenously (IV) over 30 minutes on day 1 and siltuximab IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30, 60, 90, 120, and 150 days, then every 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Arm 1- (Phase I dose level 1)- Siltuximab 6 mg/Kg every 3 weeks and Spartalizumab 300mg every 3 weeks Arm 2- (Phase I dose level 2)- Siltuximab 11 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 3 - (Phase I doe level 2a)- Siltuximab 9 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 4- (Phase II)- Siltuximab RP2D determined in Arms 1 to 3 and spartalizumab 300 mg every 3weeks
| Arm | Type | Receives |
|---|---|---|
| Treatment spartalizumab and siltuximab Phase I dose level 1 | Experimental | Biological: Siltuximab, Biological: SpartalizumabArm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| Treatment spartalizumab and siltuximab Phase I level 2 | Experimental | Biological: Siltuximab, Biological: SpartalizumabArm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| Treatment spartalizumab and siltuximab phase I level 2a | Experimental | Biological: Siltuximab, Biological: SpartalizumabArm 3 (Phase I dose level 2a) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 9 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| Treatment spartalizumab and siltuximab phase II | Experimental | Biological: Siltuximab, Biological: SpartalizumabArm 4 (Phase II ) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab at dose determined in Arm 1 to 3 IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Cytological or histologic diagnosis and metastatic pancreatic adenocarcinoma disease that has failed at least one standard regimen such as gemcitabine nab-paclitaxel or folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX).
- Patient must meet the following laboratory values at the screening visit:
- Presence of measurable disease by RECIST criteria
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Written informed consent must be obtained prior to any screening procedures.
Key exclusion criteria (19 listed)
- Prior exposure to agents targeting programmed cell death protein-1 (PD-1), PD-L1, IL-6 or the IL-6 receptor. Prior chemotherapy is allowed as long as adequate washout period of ≥ 4 weeks.
- Any untreated central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks.
- Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SiltuximabAlso: Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, SylvantGiven IV | Biological | Treatment spartalizumab and siltuximab Phase I dose level 1, Treatment spartalizumab and siltuximab Phase I level 2, Treatment spartalizumab and siltuximab phase I level 2a, Treatment spartalizumab and siltuximab phase II |
| SpartalizumabAlso: PDR001Given IV | Biological | Treatment spartalizumab and siltuximab Phase I dose level 1, Treatment spartalizumab and siltuximab Phase I level 2, Treatment spartalizumab and siltuximab phase I level 2a, Treatment spartalizumab and siltuximab phase II |
Primary outcome
Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab
Time frame: Up to 6 weeks from study start
Maximal tolerated dose (MTD )is defined as the dose at which less than one-third of the subjects experience a dose-limiting toxicity (DLT) in the first 6 weeks of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as definitely at least possibly related to study treatment treatment related that occurs within the first 6 weeks. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 2 years from study start
Response Duration
Time frame: From treatment start until progression or death, assessed up to 2 years
Progression-free Survival
Time frame: From treatment start until progression or death, assessed up to 2 years
Overall Survival Time
Time frame: From treatment start until progression or death, assessed up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olatunji Alese, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Siltuximab and Spartalizumab in people with Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab (time frame: Up to 6 weeks from study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.