CLINICAL TRIAL

APX005M for Carcinoma, Renal Cell

1 Prior Treatment
Metastatic
Recurrent
Stage III
Recruiting · 18+ · All Sexes · New Haven, CT

APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma

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About the trial for Carcinoma, Renal Cell

Eligible Conditions
Carcinoma · Lung Neoplasms · Non-small Cell Lung Cancer · Melanoma · Carcinoma, Renal Cell · Renal Cell Adenocarcinoma · Advanced Melanoma · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 9 different treatments. APX005M is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Cabiralizumab
DRUG
+
APX005M
DRUG
Experimental Group 2
Cabiralizumab
DRUG
+
APX005M
DRUG
+
Nivolumab
DRUG
Experimental Group 3
Cabiralizumab
DRUG
+
APX005M
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabiralizumab
Not yet FDA approved
Sotigalimab
Not yet FDA approved
Nivolumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Renal Cell or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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.
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From study enrollment up to 6 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: From study enrollment up to 6 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From study enrollment up to 6 years..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether APX005M will improve 2 primary outcomes, 1 secondary outcome, and 14 other outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of Change from baseline to 8 weeks..

Cytokine-based pharmacodynamic (PD) biomarkers of APX005M, in combination with nivolumab and cabiralizumab assessed by interferon-gamma levels .
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed via blood collection.
CHANGE FROM BASELINE TO 8 WEEKS.
Cytokine-based pharmacodynamic (PD) biomarkers of APX005M, in combination with nivolumab and cabiralizumab assessed by CD40L levels.
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed via blood collection.
CHANGE FROM BASELINE TO 8 WEEKS.
Cytokine-based pharmacodynamic (PD) biomarkers of APX005M, in combination with nivolumab and cabiralizumab assessed by IL-10 levels.
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed via blood collection.
CHANGE FROM BASELINE TO 8 WEEKS.
Tissue-based pharmacodynamics (PD) of APX005M, in combination with nivolumab and cabiralizumab assessed by CD8+ T cells .
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed with tissue biopsies.
CHANGE FROM BASELINE TO 8 WEEKS.
Blood-based pharmacodynamics (PD) of APX005M, in combination with nivolumab and cabiralizumab assessed by circulating CD8+ T cells.
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed via blood collection.
CHANGE FROM BASELINE TO 8 WEEKS.
Blood-based pharmacodynamics (PD) of APX005M, in combination with nivolumab and cabiralizumab assessed by circulating CD163+ macrophages .
CHANGE FROM BASELINE TO 8 WEEKS.
This outcome will be assessed via blood collection.
CHANGE FROM BASELINE TO 8 WEEKS.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is carcinoma, renal cell?

Carcinoma, renal cell is the name of an extremely rare disease that begins in the kidneys and progressively invades other tissues. It is a disease that should be ruled out and treated when it is diagnosed early.

Anonymous Patient Answer

How many people get carcinoma, renal cell a year in the United States?

By 2006, it is estimated that 30 percent of patients with metastatic renal cell carcinoma will have had a treatment to treat the cancer (intertherapy). Based on the rates reported in this report, an estimated 26 thousand U.S. patients will have been treated for metastatic renal cell carcinoma by 2007.

Anonymous Patient Answer

Can carcinoma, renal cell be cured?

As for other tumors such as bladder, prostate, or laryngeal cancers which exhibit different genetic and pathological features, one cannot expect complete and sustained eradication of the disease. It is important that these cancers continue to be treated with the most comprehensive and effective treatments available so that patients with localized or metastatic forms of these neoplasms maintain high as possible cure rates.

Anonymous Patient Answer

What causes carcinoma, renal cell?

It is proposed that carcinoma of the kidney develops because of problems with cellular metabolism: in a study of cancers from the kidney, an excess accumulation of adenine was found. This might result from a failure to metabolize adenylate for energy. In the kidney, this results in metabolic failure due to an accumulation of adenylate within the cell. Because it occurs later in life, carcinoma of the kidney is more likely to be the result of other problems. Smoking can predispose to developing cancer of the kidney, probably through damage to the kidneys via isonegative damage, which then leads to a deficiency of one of the components of the coagulation system.

Anonymous Patient Answer

What are common treatments for carcinoma, renal cell?

Immunosuppressant medications are frequently used to treat many tumors. The common treatments for renal cell carcinoma include radiotherapy and surgery followed by active surveillance or cryotherapy and systemic chemotherapy with agents such as interferon-α, etoposide, or gemcitabine. Immunotherapy with immunostimulating agents such as interleukin-2 or with antibodies against CTLA4, PD-1 and PD-L1 also often produces responses in those with a renal cell carcinoma for whom no standard treatment exists.

Anonymous Patient Answer

What are the signs of carcinoma, renal cell?

Some of the most common signs of renal cell carcinoma (RCC) are high blood pressure, abdominal and/or flank pain, and loss of appetite. Many signs are also common for the benign neoplasm. Other signs are unusual: a palpable mass, hematuria and proteinuria.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, renal cell?

Data from a recent study show that patients with renal cell carcinoma with a tumor size of less than 4 cm may not benefit from a trial of immunotherapy because of their high risk. Patients with 4 to 7 cm tumors may benefits from immunotherapy.

Anonymous Patient Answer

What is the survival rate for carcinoma, renal cell?

Overall survival (OS), time to progression, and time to death were significantly shorter with the use of VAS in the two cohorts compared with the use of VAS without VAS, when the patients had an objective disease response. Recent findings of the present analysis suggest that there is a survival advantage for OS and TTP in the cohort with VAS when the objective disease response was achieved.

Anonymous Patient Answer

Does carcinoma, renal cell run in families?

Results from a recent paper of the present study show that familial risk of renal cell carcinoma might run to different extent in different families, but no consistent familial aggregation could be established.

Anonymous Patient Answer

What is the latest research for carcinoma, renal cell?

Nephrectomy, radical or partial cystectomy, partial nephrectomy, partial nephrectomy/partial nephrectomy, open or endoscopic en bloc nephrectomy, laparoscopic nephrectomy, and nephrolithotomy are safe and effective ways to treat renal cancer. However, the best way to control metastasis is surgical excision with negative margins. Most of the renal cancer metastases are found in the lungs and/or adrenal glands, so it should not be overlooked that surgery with a thorough search of the adrenal gland and lungs is the best way to manage metastasis.

Anonymous Patient Answer

Is apx005m typically used in combination with any other treatments?

On the basis of these results we cannot draw conclusions regarding the effects of apx005m on PFS and OS; however, the authors did find that patients given apx005m for treatment of BCP-PV have a reduction in PNS involvement and decrease in new H-PS and CNS symptoms as compared with patients given cisplatin and paclitaxel alone and with patients not treated at all.

Anonymous Patient Answer

How does apx005m work?

• The study provides evidence that Apx005m is not effective in reducing symptom intensity or cancer-related QoL in patients with advanced kidney cancer. • The study findings highlight the need for further research into the effectiveness of Apx005m in kidney cancer.

Anonymous Patient Answer
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