Advanced MelanomaPhase 1NCT03502330
APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma
A Phase 1 study testing APX005M, Cabiralizumab and Nivolumab in people with Advanced Melanoma and Non-small Cell Lung Cancer, run by Yale University at 1 site in United States.
Trial summary
This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab. The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- APX005M, Cabiralizumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2018to 15 May 2024
- Phase
- Phase 1
- 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
- Must have one of the following diagnoses:
- Melanoma: Unresectable stage III or stage IV melanoma, irrespective of BRAF status, with histologic or cytologic confirmation.
- RCC: Histologic or cytologically documented, locally advanced unresectable or metastatic RCC irrespective of histologic subtype
- NSCLC: Histologic or cytologically documented, locally advanced or metastatic (i.e. Stage IIIB not eligible for definitive chemoradiotherapy, stage IV, or recurrent) NSCLC. Patients known to harbor an ALK rearrangement or EGFR mutation known to be sensitive to FDA-approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved ALK TKI or EGFR TKI, respectively. Patients with TKI-treated EGFR mutant NSCLC harboring the secondary EGFR T790M tumor must have received prior osimertinib. Patients with crizotinib-treated ALK rearranged NSCLC must have received a next generation ALK inhibitor.
- Additional Inclusion Criteria:
- Biopsy proven metastatic melanoma, NSCLC or RCC whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor, without intervening therapy.
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- At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. This site may be a target lesion as long as it will not be made unmeasurable by the biopsy procedure.
- Age ≥18, able to understand and sign the informed consent form.
- ECOG performance status < 2.
- Any number of previous treatments. Other prior systemic therapies must have been administered at least 4 weeks before administration of the study drugs; the exception to this is small molecule inhibitors, which must be stopped at least 2 weeks or after five half-lives of the drug, whichever is shorter, prior to the start of the study drugs.
- Life expectancy of at least 6 months.
- A history of previously treated brain metastases is allowed, provided that they are stable for at least 4 weeks.
- Willingness to undergo mandatory tumor biopsy prior to initiation of therapy and before the fifth cycle.
- Willingness to provide an archival specimen block, if available, for research.
- Patients must have normal organ and marrow function (as outlined in Section 3.2.2).
- Female subject 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.
- 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.
- 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.
- 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-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion. Sites for biopsy must be distinct from target lesions used for efficacy assessment.
- Prior focal radiotherapy is allowed. Radiation to brain, pulmonary or intestinal sites must be completed at least 4 weeks prior to study Day 1. 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.
- Prior surgery that requires general anesthesia must be completed at least 1 week before first dose of study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before first dose of study drug administration and patients should have recovered.
Who cannot join
- Untreated brain metastases.
- A patient who has had prior immune therapy or chemotherapy, within 4 weeks prior to study Day 1, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent will be excluded. The exception is targeted therapy that must have been completed at least 2 weeks or after 5 half-lives, which ever is shorter, prior to study Day 1. Patients who have had prior ipilimumab must have received their last dose no less than 4 weeks prior to study Day 1.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Note: Toxicity that has not recovered to ≤ Grade 1 is allowed if it meets the inclusion requirements for laboratory parameters.
- Has had prior treatment with any other CSF1R inhibitor or CD40 agonist
- 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.
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- Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to prior treatments with the exception of clinically insignificant adverse events such as alopecia, clinically insignificant laboratory abnormalities, clinically insignificant rash and Grade 2 neuropathy.
- History of grade 3-4 neurologic or cardiac toxicity or life-threatening liver toxicity poorly responsive to steroids with prior anti-PD-1/anti-PDL1 monotherapy.
- Presence of leptomeningeal disease.
- 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.
- 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, cabiralizumab or APX005M, breastfeeding must be discontinued if the mother is enrolled on this trial.
- 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.
- 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.
- Concurrent, active malignancies in addition to those being studied.
- Active (non-infectious) pneumonitis.
- Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) acute or chronic infection.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- History of myocardial infarction or unstable angina within 3 months prior to Cycle 1, Day 1.
- Prisoners, or subjects who are under compulsory detention
- Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
- History of anti-drug antibodies, severe allergic, anaphylactic, or other infusion-related reaction to a previous biologic agent
- Concomitant use of statins while on study. However, a patient using statins for over 3 months prior to study drug administration and in stable status without CK rise may be permitted to enroll
- Open wounds and active skin infections
- Uveal melanoma in the Phase Ib dose expansion trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy
This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab.
The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6 cohorts to determine the recommended phase II dose (RP2D) of APX005M.
The phase 1b dose expansion portion will study the triple drug combination separately in the three disease cohorts: melanoma, NSCLC, and RCC.
- Being tested
- APX005M, Cabiralizumab, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX005MDrug
APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
CabiralizumabDrug
Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
NivolumabDrug
Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Advanced Solid Tumors | Experimental | Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab |
| Cohort 2 Advanced Solid Tumors | Experimental | Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab; Drug: Nivolumab |
| Cohort 3 Advanced Solid Tumors | Experimental | Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab |
| Cohort 4 Advanced Solid Tumors | Experimental | Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab; Drug: Nivolumab |
| Cohort 5 Advanced Solid Tumors | Experimental | Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab |
| Cohort 6 Advanced Solid Tumors | Experimental | Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles. Receives: Drug: APX005M; Drug: Cabiralizumab; Drug: Nivolumab |
| Cohort 7 Advanced Melanoma | Experimental | Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. Receives: Drug: APX005M; Drug: Cabiralizumab; Drug: Nivolumab |
| Cohort 8 NSCLC | Experimental | Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. Receives: Drug: APX005M; Drug: Cabiralizumab |
| Cohort 9 RCC | Experimental | Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. Receives: Drug: APX005M; Drug: Cabiralizumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
Measured: From study enrollment up to 12 months.
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
This 5-point scale ranges from full functioning (0) to dead (5)
Measured: From study enrollment up to 12 months.
Secondary outcomes (1)
Efficacy Measured by Objective Response Rate (ORR)
ORR will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1. The RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD).
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start9 Jun 2018
- Primary completion5 Jan 2022
- Study completion15 May 2024
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Apexigen America, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Harriet Kluger, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502330
- Sponsor's protocol ID
- 2000021757
- Other IDs
- 5P50CA121974-15
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2018
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Djureinovic D, Weiss SA, Krykbaeva I, Qu R, Vathiotis I, Moutafi M, Zhang L, Perdigoto AL, Wei W, Anderson G, Damsky W, Hurwitz M, Johnson B, Schoenfeld D, Mahajan A, Hsu F, Miller-Jensen K, Kluger Y, Sznol M, Kaech SM, Bosenberg M, Jilaveanu LB, Kluger HM. A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. Mol Cancer. 2023 Nov 14;22(1):182. doi: 10.1186/s12943-023-01884-x.
PubMed 37964379Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non-Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clin Cancer Res. 2021 Sep 1;27(17):4757-4767. doi: 10.1158/1078-0432.CCR-21-0903. Epub 2021 Jun 17.
PubMed 34140403
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study of APX005M in Combination With Nivolumab and Cabiralizumab in Patients With Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma Whose Disease Has Progressed on Anti-PD- 1/PD-L1 Therapy
- ClinicalTrials.gov ID
- NCT03502330
- Acronym / sponsor ID
- 2000021757
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Apexigen America, Inc., National Cancer Institute (NCI)
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 18 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a phase 1/1b study to evaluate the safety, efficacy, and tolerability of APX005M in combination with nivolumab and cabiralizumab.
The phase 1 dose escalation portion of the study will enroll patients with advanced solid tumors melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC) in 6 cohorts to determine the recommended phase II dose (RP2D) of APX005M.
The phase 1b dose expansion portion will study the triple drug combination separately in the three disease cohorts: melanoma, NSCLC, and RCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: CabiralizumabCabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles. |
| Cohort 2 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: Cabiralizumab, Drug: NivolumabNivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles. |
| Cohort 3 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: CabiralizumabCabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles. |
| Cohort 4 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: Cabiralizumab, Drug: NivolumabNivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles. |
| Cohort 5 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: CabiralizumabCabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles. |
| Cohort 6 Advanced Solid Tumors | Experimental | Drug: APX005M, Drug: Cabiralizumab, Drug: NivolumabNivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles. |
| Cohort 7 Advanced Melanoma | Experimental | Drug: APX005M, Drug: Cabiralizumab, Drug: NivolumabPatients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. |
| Cohort 8 NSCLC | Experimental | Drug: APX005M, Drug: CabiralizumabPatients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. |
| Cohort 9 RCC | Experimental | Drug: APX005M, Drug: Cabiralizumab, Drug: NivolumabPatients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Melanoma: Unresectable stage III or stage IV melanoma, irrespective of BRAF status, with histologic or cytologic confirmation.
- RCC: Histologic or cytologically documented, locally advanced unresectable or metastatic RCC irrespective of histologic subtype
- NSCLC: Histologic or cytologically documented, locally advanced or metastatic (i.e. Stage IIIB not eligible for definitive chemoradiotherapy, stage IV, or recurrent) NSCLC. Patients known to harbor an ALK rearrangement or EGFR mutation known to be sensitive to FDA-approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved ALK TKI or EGFR TKI, respectively. Patients with TKI-treated EGFR mutant NSCLC harboring the secondary EGFR T790M tumor must have received prior osimertinib. Patients with crizotinib-treated ALK rearranged NSCLC must have received a next generation ALK inhibitor.
- Biopsy proven metastatic melanoma, NSCLC or RCC whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor, without intervening therapy.
- At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. This site may be a target lesion as long as it will not be made unmeasurable by the biopsy procedure.
Key exclusion criteria (24 listed)
- Untreated brain metastases.
- A patient who has had prior immune therapy or chemotherapy, within 4 weeks prior to study Day 1, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent will be excluded. The exception is targeted therapy that must have been completed at least 2 weeks or after 5 half-lives, which ever is shorter, prior to study Day 1. Patients who have had prior ipilimumab must have received their last dose no less than 4 weeks prior to study Day 1.
- Has had prior treatment with any other CSF1R inhibitor or CD40 agonist
- 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.
- Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to prior treatments with the exception of clinically insignificant adverse events such as alopecia, clinically insignificant laboratory abnormalities, clinically insignificant rash and Grade 2 neuropathy.
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 |
|---|---|---|
| APX005MAPX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion. | Drug | Cohort 1 Advanced Solid Tumors, Cohort 2 Advanced Solid Tumors, Cohort 3 Advanced Solid Tumors, Cohort 4 Advanced Solid Tumors, Cohort 5 Advanced Solid Tumors, Cohort 6 Advanced Solid Tumors, Cohort 7 Advanced Melanoma, Cohort 8 NSCLC, Cohort 9 RCC |
| CabiralizumabCabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion. | Drug | Cohort 1 Advanced Solid Tumors, Cohort 2 Advanced Solid Tumors, Cohort 3 Advanced Solid Tumors, Cohort 4 Advanced Solid Tumors, Cohort 5 Advanced Solid Tumors, Cohort 6 Advanced Solid Tumors, Cohort 7 Advanced Melanoma, Cohort 8 NSCLC, Cohort 9 RCC |
| NivolumabNivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion. | Drug | Cohort 2 Advanced Solid Tumors, Cohort 4 Advanced Solid Tumors, Cohort 6 Advanced Solid Tumors, Cohort 7 Advanced Melanoma, Cohort 9 RCC |
Primary outcome
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
Time frame: From study enrollment up to 12 months.
AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
Time frame: From study enrollment up to 12 months.
This 5-point scale ranges from full functioning (0) to dead (5)
1 secondary outcome
Efficacy Measured by Objective Response Rate (ORR)
Time frame: Six months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37964379Djureinovic D, Weiss SA, Krykbaeva I, Qu R, Vathiotis I, Moutafi M, Zhang L, Perdigoto AL, Wei W, Anderson G, Damsky W, Hurwitz M, Johnson B, Schoenfeld D, Mahajan A, Hsu F, Miller-Jensen K, Kluger Y, Sznol M, Kaech SM, Bosenberg M, Jilaveanu LB, Kluger HM. A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. Mol Cancer. 2023 Nov 14;22(1):182. doi: 10.1186/s12943-023-01884-x.
- Derived from this study: PubMed 34140403Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non-Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clin Cancer Res. 2021 Sep 1;27(17):4757-4767. doi: 10.1158/1078-0432.CCR-21-0903. Epub 2021 Jun 17.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APX005M, Cabiralizumab and Nivolumab in people with Advanced Melanoma and Non-small Cell Lung Cancer, run by Yale University at 1 site 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 22 inclusion and 24 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Aug 2023). 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?
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs) (time frame: From study enrollment up to 12 months.). 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?
On the ClinicalTrials.gov record for NCT03502330, which also lists 2 linked publications.
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 3 Jul 2024.