Advanced MelanomaPhase 1NCT04495257
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)
A Phase 1 study testing Nivolumab, Ipilimumab and APX005M in people with Advanced Melanoma and Renal Cell Carcinoma, run by Yale University at 2 sites in United States.
Trial summary
This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Renal Cell Carcinoma
- What is being tested?
- Nivolumab, Ipilimumab and APX005M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Sep 2020to 4 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 1. At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. The biopsy may be waived if not feasible upon discussion with the study PIs. This site may be a target lesion as long as it will not be rendered unmeasurable by the biopsy procedure.
- 2. Age ≥18, able to understand and sign the informed consent form 3. ECOG performance status < 2 4. No prior systemic immune therapy for advanced (unresectable) disease. Prior targeted therapy is allowed. Adjuvant therapy is allowed provided that at least 6 months have lapsed from the last dose of an immune checkpoint inhibitor. Prior small molecule inhibitors must be discontinued within 2 weeks before starting study.
- 5. Life expectancy of at least 6 months 6. A history of previously treated brain metastases is allowed, provided that they are stable for at least 4 weeks.
- 7. Willingness to undergo tumor biopsy (if amenable) prior to initiation of therapy and on trial.
- 8. Willingness to provide an archival specimen block, if available, for research 9. Normal organ function . 10. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- 11. Female subjects of childbearing potential should be willing to use a highly effective contraception (hormonal or IUD) or be surgically sterile, or abstain from heterosexual activity for a period of at least 5 months after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
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- 12. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through at least 7 months after the last dose of study drug.
- 13. Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria. Tumor sites situated in a previously irradiated area, or in an area subjected to other loco-reginal therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
- 14. Prior focal radiotherapy is allowed. Radiation to pulmonary or intestinal sites must be completed at least 1 week prior to study Day 1. Radiation to the brain must be completed within 4 weeks prior to initiation of treatment. There is no time restriction prior to study Day 1 for patients who have received radiation to bone, soft tissue or other sites. No radiopharmaceuticals (strontium, samarium) within 8 weeks before first dose of study drug administration.
- 15. Major surgery must be completed at least 2 weeks prior to the first dose of study drug administration and patients should have recovered. Wounds must be healed.
Who cannot join
- 1. Untreated brain metastases. 2. A patient who has had prior treatment with immune therapy for advanced disease. Prior immune checkpoint inhibitors as adjuvant therapy is allowed provided at least 6 months have lapsed from the last dose. Prior targeted therapy is allowed as long as 2 weeks have passed.
- 3. Use of corticosteroids to control immune related adverse events at enrollment will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 2 weeks. Low-dose steroid use (≤10 mg of prednisone or equivalent) as corticosteroid replacement therapy for primary or secondary adrenal insufficiency is allowed.
- 4. Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to prior treatments with the exceptions such as alopecia listed in Table 2.
- 5. History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1/anti-PD-L1 therapy in the adjuvant setting.
- 6. Presence of leptomeningeal disease. 7. Has active autoimmune disease unrelated to use of immune checkpoint inhibitors that has required systemic treatment in the past year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- 8. Pregnancy or breast feeding. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, ipilimumab or APX005M, breastfeeding must be discontinued if the mother is enrolled on this trial.
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- 9. Patients may not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- 10. Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study.
- 11. Concurrent, active malignancies in addition to those being studied (other than cutaneous squamous cell carcinoma or basal cell carcinoma).
- 12. Active (non-infectious) pneumonitis. 13. Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) acute or chronic infection.
- 14. Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- 15. History of myocardial infarction or unstable angina within 3 months prior to Cycle 1, Day 1.
- 16. Prisoners, or subjects who are under compulsory detention 17. Open wounds and active skin infections
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Cancer Center
New Haven, Connecticut, 06519
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma
This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
Read the detailed description
This trial is a phase 1 study to evaluate the safety and tolerability of APX005M in combination with nivolumab and ipilimumab. The study will enroll patients with advanced solid tumors (melanoma, RCC) to determine the recommended phase II dosing (RP2D) of APX005M in combination with ipilimumab 1mg/kg and nivolumab 3 mg/kg (IPI1 NIVO3) every 3 weeks for four cycles followed by APX005M in combination with nivolumab 360mg every 3 weeks. APX005M will be administered at a dose of 0.1 mg/kg every 3 weeks in Dose Level 1 (DL1) and escalated to 0.3 mg/kg every 3 weeks in Dose Level 2 (DL2) (Table 1). The IPI1 NIVO3 regimen is approved for patients with metastatic RCC.
APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. Nivolumab is a humanized IgG4 monoclonal antibody directed against PD-1. Ipilimumab is a humanized IgG1κ monoclonal antibody directed against CTLA-4.
Primary Objective
- To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab
- To determine the recommended RP2D of APX005M in combination with nivolumab and ipilimumab in patients with unresectable metastatic melanoma or renal cell carcinoma.
Secondary Objective
- Determine rate and pattern of AEs in patients treated with APX005M in combination with nivolumab and ipilimumab
- Conditions
- Advanced Melanoma, Renal Cell Carcinoma
- Being tested
- Nivolumab, Ipilimumab, APX005M
- 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.
NivolumabDrug
Nivolumab 3mg/kg intravenously (IV) every 3 weeks for the first 4 treatments and then will be given at 360mg every 3 weeks thereafter
IpilimumabDrug
Ipilimumab 1mg/kg intravenously (IV) every 3 weeks for a total of 4 treatments
APX005MDrug
APX005M 0.3mg/kg intravenously (IV) every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (DL1) | Experimental | DL1 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.1mg/kg for the induction phase. After 4 cycles, participants will be treated with 360mg of nivolumab and APX005M every 3 weeks. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: APX005M |
| Dose Level 2 (DL2) | Experimental | DL2 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.3mg/kg for the induction phase. After 4 cycles we will treat with 360mg of nivolumab and APX005M every 3 weeks. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: APX005M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
The safety and tolerability of APX005M in combination with nivolumab and ipilimumab will be assessed by monitoring the of dose-limiting toxicities (DLTs) . This will be defined by both DLTs and any of the following AEs (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0) which occur during the first 9 weeks of ipilimumab + nivolumab + APX005M administration that is not clearly due to a cause other than study medication. DLTs in this study do not include reversible grade 3-4 irAEs, that are acceptable and expected with treatment regimens containing ipilimumab and nivolumab, but do include severe, irreversible, non-endocrine adverse events
Measured: Up to 2 years
Recommended dose of APX005M
This outcome will determine the recommended phase II dose (RP2D) of APX005M in combination with nivolumab and ipilimumab in patients with unresectable or metastatic melanoma or renal cell carcinoma (RCC). The RP2D will be defined as a triplet regimen that does not exceed a grade 3-4 irAE rate of approximately 55% or lead to a significant increase in dose limiting toxicities (DLTs) specific to an ipilimumab + nivolumab containing regimen, particularly those which are severe, irreversible, and non-endocrine related events.
Measured: Up to 2 years
Secondary outcomes (2)
Adverse Events Rate
The rate of AEs in patients treated with APX005M in combination with nivolumab and ipilimumab will be assessed.
Measured: Up to 2 years
Adverse Events Frequency
The frequency of AE type in patients treated with APX005M in combination with nivolumab and ipilimumab will be assessed.
Measured: 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 posted31 Jul 2020
- Study start14 Sep 2020
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Yale 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Apexigen America, Inc.
- Responsible party
- Principal investigator, Harriet Kluger, Yale University
- Investigators
- Harriet Kluger, MD, Principal investigator, Yale UniversitySarah Weiss, MD, Principal investigator, Yale UniversityKelly Olino, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495257
- Sponsor's protocol ID
- 2000026830
- Status last verified
- Jun 2025
- First submitted
- 28 Jul 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04495257
- Acronym / sponsor ID
- 2000026830
- Conditions
- Advanced Melanoma, Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Apexigen America, Inc.
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 31 Jul 2020 (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 is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
Detailed description
This trial is a phase 1 study to evaluate the safety and tolerability of APX005M in combination with nivolumab and ipilimumab. The study will enroll patients with advanced solid tumors (melanoma, RCC) to determine the recommended phase II dosing (RP2D) of APX005M in combination with ipilimumab 1mg/kg and nivolumab 3 mg/kg (IPI1 NIVO3) every 3 weeks for four cycles followed by APX005M in combination with nivolumab 360mg every 3 weeks. APX005M will be administered at a dose of 0.1 mg/kg every 3 weeks in Dose Level 1 (DL1) and escalated to 0.3 mg/kg every 3 weeks in Dose Level 2 (DL2) (Table 1). The IPI1 NIVO3 regimen is approved for patients with metastatic RCC.
APX005M is a humanized IgG1 agonistic monoclonal antibody that binds CD40. Nivolumab is a humanized IgG4 monoclonal antibody directed against PD-1. Ipilimumab is a humanized IgG1κ monoclonal antibody directed against CTLA-4.
Primary Objective
- To assess the safety and tolerability of APX005M in combination with nivolumab and ipilimumab
- To determine the recommended RP2D of APX005M in combination with nivolumab and ipilimumab in patients with unresectable metastatic melanoma or renal cell carcinoma.
Secondary Objective
- Determine rate and pattern of AEs in patients treated with APX005M in combination with nivolumab and ipilimumab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (DL1) | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: APX005MDL1 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.1mg/kg for the induction phase. After 4 cycles, participants will be treated with 360mg of nivolumab and APX005M every 3 weeks. |
| Dose Level 2 (DL2) | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: APX005MDL2 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.3mg/kg for the induction phase. After 4 cycles we will treat with 360mg of nivolumab and APX005M every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. The biopsy may be waived if not feasible upon discussion with the study PIs. This site may be a target lesion as long as it will not be rendered unmeasurable by the biopsy procedure.
- 2. Age ≥18, able to understand and sign the informed consent form 3. ECOG performance status < 2 4. No prior systemic immune therapy for advanced (unresectable) disease. Prior targeted therapy is allowed. Adjuvant therapy is allowed provided that at least 6 months have lapsed from the last dose of an immune checkpoint inhibitor. Prior small molecule inhibitors must be discontinued within 2 weeks before starting study.
- 5. Life expectancy of at least 6 months 6. A history of previously treated brain metastases is allowed, provided that they are stable for at least 4 weeks.
- 7. Willingness to undergo tumor biopsy (if amenable) prior to initiation of therapy and on trial.
- 8. Willingness to provide an archival specimen block, if available, for research 9. Normal organ function . 10. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Key exclusion criteria (13 listed)
- 1. Untreated brain metastases. 2. A patient who has had prior treatment with immune therapy for advanced disease. Prior immune checkpoint inhibitors as adjuvant therapy is allowed provided at least 6 months have lapsed from the last dose. Prior targeted therapy is allowed as long as 2 weeks have passed.
- 3. Use of corticosteroids to control immune related adverse events at enrollment will not be allowed, and patients who previously required corticosteroids for symptom control must be off steroids for at least 2 weeks. Low-dose steroid use (≤10 mg of prednisone or equivalent) as corticosteroid replacement therapy for primary or secondary adrenal insufficiency is allowed.
- 4. Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to prior treatments with the exceptions such as alopecia listed in Table 2.
- 5. History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1/anti-PD-L1 therapy in the adjuvant setting.
- 6. Presence of leptomeningeal disease. 7. Has active autoimmune disease unrelated to use of immune checkpoint inhibitors that has required systemic treatment in the past year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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 |
|---|---|---|
| NivolumabNivolumab 3mg/kg intravenously (IV) every 3 weeks for the first 4 treatments and then will be given at 360mg every 3 weeks thereafter | Drug | Dose Level 1 (DL1), Dose Level 2 (DL2) |
| IpilimumabIpilimumab 1mg/kg intravenously (IV) every 3 weeks for a total of 4 treatments | Drug | Dose Level 1 (DL1), Dose Level 2 (DL2) |
| APX005MAPX005M 0.3mg/kg intravenously (IV) every 3 weeks | Drug | Dose Level 1 (DL1), Dose Level 2 (DL2) |
Primary outcome
Dose-limiting toxicities
Time frame: Up to 2 years
The safety and tolerability of APX005M in combination with nivolumab and ipilimumab will be assessed by monitoring the of dose-limiting toxicities (DLTs) . This will be defined by both DLTs and any of the following AEs (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0) which occur during the first 9 weeks of ipilimumab + nivolumab + APX005M administration that is not clearly due to a cause other than study medication. DLTs in this study do not include reversible grade 3-4 irAEs, that are acceptable and expected with treatment regimens containing ipilimumab and nivolumab, but do include severe, irreversible, non-endocrine adverse events
Recommended dose of APX005M
Time frame: Up to 2 years
This outcome will determine the recommended phase II dose (RP2D) of APX005M in combination with nivolumab and ipilimumab in patients with unresectable or metastatic melanoma or renal cell carcinoma (RCC). The RP2D will be defined as a triplet regimen that does not exceed a grade 3-4 irAE rate of approximately 55% or lead to a significant increase in dose limiting toxicities (DLTs) specific to an ipilimumab + nivolumab containing regimen, particularly those which are severe, irreversible, and non-endocrine related events.
2 secondary outcomes
Adverse Events Rate
Time frame: Up to 2 years
Adverse Events Frequency
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- 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.
Harriet Kluger, MD principal investigator
Yale University
Sarah Weiss, MD principal investigator
Yale University
Kelly Olino, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab, Ipilimumab and APX005M in people with Advanced Melanoma and Renal Cell Carcinoma, run by Yale University at 2 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 10 inclusion and 13 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 11 Jun 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicities (time frame: Up to 2 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 11 Jun 2026.