Trial Summary
What is the purpose of this trial?
To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude patients who have not recovered from adverse events of previous treatments to a certain level, and those with unresolved toxicity from previous therapies. It's best to discuss your specific medications with the trial investigators.
What data supports the idea that ADI-PEG 20 + Chemotherapy for Prostate Cancer is an effective treatment?
The available research does not provide specific data on the effectiveness of ADI-PEG 20 + Chemotherapy for Prostate Cancer. The studies mentioned focus on other treatments and drugs for prostate cancer, such as sipuleucel-T, radium-223, and siltuximab, but do not include information on ADI-PEG 20. Therefore, there is no direct evidence from the provided research to support the effectiveness of ADI-PEG 20 + Chemotherapy for Prostate Cancer.12345
What safety data exists for ADI-PEG 20 + chemotherapy in prostate cancer?
The provided research does not contain specific safety data for ADI-PEG 20 combined with chemotherapy in prostate cancer. However, it includes safety data for amivantamab (Rybrevant) in non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions, showing its safety and antitumor activity when combined with chemotherapy. Additionally, a phase 1 study of ADI-PEG 20 in mesothelioma evaluated its safety in combination with pemetrexed and cisplatin, but not specifically for prostate cancer.678910
Eligibility Criteria
This trial is for men over 18 with aggressive variant prostate cancer (AVPC) that has spread, as shown by scans. They must consent to tissue collection and agree to birth control if their partners can have children. Participants need good organ function, low testosterone levels on treatment, and a performance status score of ≤2. Men who've had more than one chemo or specific drugs for CRPC aren't eligible.Inclusion Criteria
My prostate cancer has been confirmed by a lab test.
My organs and bone marrow are functioning well, as tested within the last week.
You have proof that your disease is getting worse based on specific measurements or tests.
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Exclusion Criteria
I have been treated for prostate cancer with carboplatin, cisplatin, or cabazitaxel.
I have active hepatitis or chronic liver disease.
I have another cancer with a high chance of coming back within 2 years.
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Treatment Details
Interventions
- Amivantamab (Monoclonal Antibodies)
- Tepotinib (Tyrosine Kinase Inhibitor)
Trial OverviewThe study aims to find the safest dose of ADI-PEG20 when used with carboplatin and cabazitaxel in treating AVPC. It's a phase I/II trial which means they're looking at safety, side effects, and early signs of how well it works.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and Monotherapy MaintenanceExperimental Treatment3 Interventions
Participants will be assigned to a study group and dose level of ADI-PEG20 based on when participant join this study. Up to 2 dose levels of ADI-PEG20 may be tested. Up to 15 participants will be enrolled per dose level.
Amivantamab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Rybrevant for:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
🇪🇺 Approved in European Union as Rybrevant for:
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
An Observational Study of Concomitant Use of Emerging Therapies and Denosumab or Zoledronic Acid in Prostate Cancer. [2019]This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denosumab or zoledronic acid.
A phase 1 study of a chimeric monoclonal antibody against interleukin-6, siltuximab, combined with docetaxel in patients with metastatic castration-resistant prostate cancer. [2021]Siltuximab is a chimeric, anti-interleukin-6 monoclonal antibody with potential therapeutic benefit in castration-resistant prostate cancer (CRPC) patients. We assessed the safety and tolerability of siltuximab in combination with docetaxel, the pharmacokinetics of docetaxel alone and with siltuximab, and the efficacy and pharmacodynamics of siltuximab plus docetaxel.
Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer. [2022]To investigate whether radium-223 increases peripheral immune responses to sipuleucel-T in men with bone-predominant, minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: experience at Dana Farber and in the PROCEED Registry. [2022]Sipuleucel-T has demonstrated survival benefit in phase 3 trials but is utilized in few men with metastatic castration-resistant prostate cancer (mCRPC) in part due to low rates of PSA and objective response. Given the requirement to develop immune-mediated antitumor activity as vaccine-based therapy, sipuleucel-T may have delayed clinical activity. We explored this in a cohort of men from PROCEED (NCT01306890), an FDA-requested outcomes registry, and in a separate institutional cohort of mCRPC patients treated with sipuleucel-T at Dana-Farber Cancer Institute (DFCI).
Novel clinical trials in androgen-independent prostate cancer. [2019]Current treatments for androgen-independent prostate cancer have not shown a definitive increase in survival. Several novel drugs have made their way through preclinical testing into early clinical trials. Targets discussed in this review include apoptosis, antiangiogenesis, growth factor receptors or associated tyrosine kinases, and tumor-associated antigens targeted by vaccines. Research in this area includes testing combinations of previously studied chemotherapeutic agents as well as identifying and testing novel agents. It is these drugs, either alone or in combination, that are designed to target strategic pathways to improve survival and increase quality of life in prostate cancer patients. This review focuses on the novel agents being tested with chemotherapy in metastatic prostate cancer.
Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Amivantamab has been approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions who have had disease progression during or after platinum-based chemotherapy. Phase 1 data showed the safety and antitumor activity of amivantamab plus carboplatin-pemetrexed (chemotherapy). Additional data on this combination therapy are needed.
Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after Progression on Platinum-Based Chemotherapy. [2023]This study is a comprehensive review of the clinical pharmacology, pharmacokinetics, efficacy, safety, and clinical applicability of amivantamab-vmjw for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutation.
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]Amivantamab was approved on May 21st, 2021, by United States food and drug administration with the brand name Rybervant, used particularly for adult patients with exon20 insertion of epithelial growth factor receptor with locally advanced metastatic non-small cell lung cancer.
Amivantamab: First Approval. [2021]Amivantamab (amivantamab-vmjw; Rybrevant™), a bispecific monoclonal antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET), is being developed by Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.
Expansion Phase 1 Study of Pegargiminase Plus Pemetrexed and Cisplatin in Patients With Argininosuccinate Synthetase 1-Deficient Mesothelioma: Safety, Efficacy, and Resistance Mechanisms. [2022]Pegargiminase (ADI-PEG 20; ADI) degrades arginine and potentiates pemetrexed (Pem) cytotoxicity in argininosuccinate synthetase 1 (ASS1)-deficient malignant pleural mesothelioma (MPM). We conducted a phase 1 dose-expansion study at the recommended phase 2 dose of ADI-PEG 20 with Pem and cisplatin (ADIPemCis), to further evaluate arginine-lowering therapy in ASS1-deficient MPM and explore the mechanisms of resistance.
Platelet-derived growth factor receptor inhibitor imatinib mesylate and docetaxel: a modular phase I trial in androgen-independent prostate cancer. [2018]To study the platelet-derived growth factor receptor (PDGFR) inhibitor imatinib mesylate in androgen-independent prostate cancer (AIPC), alone and in combination with docetaxel, we designed a modular phase I trial. Our goals were to (1) evaluate the toxicity and maximum-tolerated dose of docetaxel with imatinib, and (2) evaluate the decline of prostate-specific antigen (PSA) induced by imatinib alone, and imatinib and docetaxel.
Inhibition of growth and metastasis of orthotopic human prostate cancer in athymic mice by combination therapy with pegylated interferon-alpha-2b and docetaxel. [2019]We evaluated whether treatment of orthotopic human prostate cancer in nude mice with pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) and docetaxel could represent a two-compartment targeting of primary tumor (tumor cells and tumor-associated endothelial cells) and inhibition of regional lymph node metastasis. The antiangiogenic properties of IFN were combined with the cytotoxic properties of docetaxel, resulting in apoptosis of both tumor cells and endothelium and hence significant inhibition of primary tumor growth. We first determined the optimal biological dose of PEG-IFN-alpha-2b (70,000 IU/week) necessary to down-regulate the expression of basic fibroblast growth factor, matrix metalloprotease-9, and matrix metalloprotease-2. The therapeutic dose of docetaxel (10 mg/kg/week) was determined by efficacy and minimal body weight loss. Therapy beginning 3 days after orthotopic implantation of PC3-MM2 prostate cancer cells reduced tumor weight by 37% in mice treated with PEG-IFN-alpha-2b, by 60% in mice treated with docetaxel, and by 83% in those given both drugs. PEG-IFN-alpha-2b also induced apoptosis of tumor-associated endothelial cells and hence a significant decrease in microvessel density. Our data indicate that the combination of PEG-IFN-alpha and docetaxel inhibits neoplastic angiogenesis by inducing a decrease in the local production of proangiogenic molecules by tumor cells, resulting in increased apoptosis of tumor-associated endothelial cells.
Intermittent chemotherapy in patients with metastatic androgen-independent prostate cancer: results from ASCENT, a double-blinded, randomized comparison of high-dose calcitriol plus docetaxel with placebo plus docetaxel. [2018]Survival in patients with metastatic, chemotherapy-naive, androgen-independent prostate cancer (AIPC) is improved with 10 to 12 cycles of docetaxel-containing chemotherapy but further management is undefined. In the current study, the authors examined retreatment with the same regimen after a treatment holiday.
Thalidomide/estramustine/paclitaxel in metastatic androgen-independent prostate cancer. [2016]This is a phase I/II trial of thalidomide with estramustine and paclitaxel in men with androgen-independent prostate cancer (AIPC) who underwent previous chemotherapy.