Renal Cell Carcinoma, Clear CellPhase 2SMT112-216NCT07877194
A Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab for Advanced Renal Cancer
A Phase 2 study testing Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab and Ivonescimab combined with Ipilimumab in people with Renal Cell Carcinoma, Clear Cell, run by Summit Therapeutics at 2 sites in 2 countries.
Trial summary
This study aims to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell
- What is being tested?
- Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab and Ivonescimab combined with Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2026to 12 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of the designated study procedures required by the study.
- Age ≥ 18 years both male and female.
- Karnofsky Performance Status Score (KPS) ≥ 70%.
- Expected survival ≥ 6 months.
- According to RECIST v1.1, there is at least one measurable lesion that is suitable for repeated and accurate measurements.
- Histologically or cytologically, pathologically confirmed renal cancer with a clear cell carcinoma component (ccRCC).
- Locally advanced or metastatic RCC not amenable to curative surgery or radiotherapy.
- Adequate organ function.
Who cannot join
- Locally advanced disease that is resectable or suitable for local therapy with curative intent.
- Histologically or cytologically confirmed renal non-clear cell carcinoma (nccRCC).
- Presence of active central nervous system (CNS) metastases.
- Previous anti-tumor therapy toxicity has not been resolved.
- Have other malignancies within 5 years prior to enrollment.
- Known presence of active pulmonary tuberculosis and active syphilis infection.
- Other reasons for ineligibility as evaluated by investigator.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: A Phase II Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab in the Treatment of Advanced Renal Cancer
This study aims to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
Read the detailed description
This is a multiregional, randomized, open-label Phase II clinical study to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC). Approximately 100 participants will be randomized across five treatment arms: ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab in combination with ipilimumab.
- Conditions
- Renal Cell Carcinoma, Clear Cell
- Being tested
- Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab, Ivonescimab combined with Ipilimumab, Ivonescimab, Nivolumab combined with Ipilimumab
- Keywords
- Ivonescimab, ccRCC, Advanced Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab (dose level 1) combined with CadonilimabDrug
Subjects will receive Ivonescimab (dose level 1) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
Ivonescimab (dose level 2) combined with CadonilimabDrug
Ivonescimab (dose level 2) combined with Cadonilimab via intravenous infusion (IV) up to 2 years.
Ivonescimab combined with IpilimumabDrug
Ivonescimab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Ivonescimab for maintenance treatment up to 2 years total.
IvonescimabDrug
Ivonescimab monotherapy via intravenous infusion (IV) up to 2 years.
Nivolumab combined with IpilimumabDrug
Nivolumab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Nivolumab will be used for maintenance treatment up to 2 years total.
| Study group | Role | What they receive |
|---|---|---|
| Ivo 1 + Cado | Experimental | Ivonescimab (dose level 1) + Cadonilimab Receives: Drug: Ivonescimab (dose level 1) combined with Cadonilimab |
| Ivo 2 + Cado | Experimental | Ivonescimab (dose level 2) + Cadonilimab Receives: Drug: Ivonescimab (dose level 2) combined with Cadonilimab |
| Ivo + Ipi | Experimental | Ivonescimab + Ipilimumab Receives: Drug: Ivonescimab combined with Ipilimumab |
| Ivo | Experimental | Ivonescimab Receives: Drug: Ivonescimab |
| Nivo + Ipi | Active comparator | Nivolumab + Ipilimumab Receives: Drug: Nivolumab combined with Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR per RECIST v1.1 by investigator
Measured: From randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Adverse Events (AEs)
Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment
Measured: At the time of initiation of the first dose through 90 days after the last dose of study treatment.
Secondary outcomes (6)
Disease Control Rate (DCR)
DCR assessed by investigator according to RECIST v1.1.
Measured: From randomization to first occurrence of disease progression, death or study completion, whichever came first, assessed up to 3 years.
Duration of Response (DoR)
Duration of response (DoR) assessed by investigator according to RECIST v1.1.
Measured: From time of first recorded response randomization to progressive disease, or death or study completion, whichever came first, assessed up to 3 years.
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization to the first documented disease progression (per RECIST v1.1) assessed by investigator or death due to any cause, whichever occurs first.
Measured: From randomization to progressive disease or death, whichever came first, assessed up to 3 years.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Measured: From randomization to death, assessed up to 4 years.
Pharmacokinetics (PK)
Serum drug concentration at different time points after administration
Measured: From first dose of study drug until end of treatment, assessed up to 3 years.
Anti-Drug Antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Measured: From time of initiation of first dose to 30 days after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion12 Apr 2029 (estimated)
- Study completion12 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma, Clear CellStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summit Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877194
- Sponsor's protocol ID
- SMT112-216
- Other IDs
- AK112-216
- Acronym
- SMT112-216
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab in the Treatment of Advanced Renal Cancer
- ClinicalTrials.gov ID
- NCT07877194
- Acronym / sponsor ID
- SMT112-216 / SMT112-216
- Conditions
- Renal Cell Carcinoma, Clear Cell
- Keywords
- Ivonescimab, ccRCC, Advanced Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Summit TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 12 Apr 2029 (estimated)
- Study completion
- 12 Dec 2029 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
Detailed description
This is a multiregional, randomized, open-label Phase II clinical study to evaluate the safety and efficacy of Ivonescimab alone or in combination with Cadonilimab or Ipilimumab in the treatment of advanced clear cell renal cell carcinoma (ccRCC). Approximately 100 participants will be randomized across five treatment arms: ivonescimab in combination with cadonilimab, ivonescimab in combination with ipilimumab, ivonescimab monotherapy, or nivolumab in combination with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ivo 1 + Cado | Experimental | Drug: Ivonescimab (dose level 1) combined with CadonilimabIvonescimab (dose level 1) + Cadonilimab |
| Ivo 2 + Cado | Experimental | Drug: Ivonescimab (dose level 2) combined with CadonilimabIvonescimab (dose level 2) + Cadonilimab |
| Ivo + Ipi | Experimental | Drug: Ivonescimab combined with IpilimumabIvonescimab + Ipilimumab |
| Ivo | Experimental | Drug: IvonescimabIvonescimab |
| Nivo + Ipi | Active comparator | Drug: Nivolumab combined with IpilimumabNivolumab + Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of the designated study procedures required by the study.
- Age ≥ 18 years both male and female.
- Karnofsky Performance Status Score (KPS) ≥ 70%.
- Expected survival ≥ 6 months.
- According to RECIST v1.1, there is at least one measurable lesion that is suitable for repeated and accurate measurements.
Key exclusion criteria (7 listed)
- Locally advanced disease that is resectable or suitable for local therapy with curative intent.
- Histologically or cytologically confirmed renal non-clear cell carcinoma (nccRCC).
- Presence of active central nervous system (CNS) metastases.
- Previous anti-tumor therapy toxicity has not been resolved.
- Have other malignancies within 5 years prior to enrollment.
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 |
|---|---|---|
| Ivonescimab (dose level 1) combined with CadonilimabSubjects will receive Ivonescimab (dose level 1) combined with Cadonilimab via intravenous infusion (IV) up to 2 years. | Drug | Ivo 1 + Cado |
| Ivonescimab (dose level 2) combined with CadonilimabIvonescimab (dose level 2) combined with Cadonilimab via intravenous infusion (IV) up to 2 years. | Drug | Ivo 2 + Cado |
| Ivonescimab combined with IpilimumabIvonescimab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Ivonescimab for maintenance treatment up to 2 years total. | Drug | Ivo + Ipi |
| IvonescimabIvonescimab monotherapy via intravenous infusion (IV) up to 2 years. | Drug | Ivo |
| Nivolumab combined with IpilimumabNivolumab combined with Ipilimumab via intravenous infusion (IV) up to 4 cycles. Afterward, Nivolumab will be used for maintenance treatment up to 2 years total. | Drug | Nivo + Ipi |
Primary outcome
Objective Response Rate (ORR)
Time frame: From randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
ORR per RECIST v1.1 by investigator
Adverse Events (AEs)
Time frame: At the time of initiation of the first dose through 90 days after the last dose of study treatment.
Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: From randomization to first occurrence of disease progression, death or study completion, whichever came first, assessed up to 3 years.
Duration of Response (DoR)
Time frame: From time of first recorded response randomization to progressive disease, or death or study completion, whichever came first, assessed up to 3 years.
Progression Free Survival (PFS)
Time frame: From randomization to progressive disease or death, whichever came first, assessed up to 3 years.
Overall Survival (OS)
Time frame: From randomization to death, assessed up to 4 years.
Pharmacokinetics (PK)
Time frame: From first dose of study drug until end of treatment, assessed up to 3 years.
Anti-Drug Antibodies (ADA)
Time frame: From time of initiation of first dose to 30 days after end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab and Ivonescimab combined with Ipilimumab in people with Renal Cell Carcinoma, Clear Cell, run by Summit Therapeutics at 2 sites in 2 countries.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summit Clinical Trial Information (1-833-256-0522, medicalinformation@smmttx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.). The study lists 2 primary outcomes in all. 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 16 Oct 2026.