Triple immunotherapy cocktail tested in advanced cancers
NCT ID NCT04495257
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase study tested an experimental drug called APX005M added to two standard immunotherapies (nivolumab and ipilimumab) in 26 people with advanced melanoma or kidney cancer who had not received prior immune therapy. The main goals were to check safety and find the best dose. The study is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APX005M (an experimental immune-boosting drug) combined with nivolumab and ipilimumab (two approved immunotherapy drugs)
- What this could lead to
- If this combination proves safe and effective, it could lead to a new treatment option for advanced melanoma and kidney cancer.
- What could go wrong
- This is a very early Phase 1 trial with only 26 participants, focused on safety and dosing. The combination may cause severe side effects, and it is too soon to know if it works better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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26 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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. Exclusion Criteria: * 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. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yale Cancer Center
New Haven, Connecticut, 06519, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
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Other studies related to the condition(s) this trial covers.
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