Pegilodecakin for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Prostate Cancer+13 More
Pegilodecakin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called pegilodecakin is safe and tolerable in people with cancer.

See full description

Eligible Conditions

  • Prostate Cancer
  • Non-small Cell Lung Carcinoma
  • Colorectal Carcinoma (CRC)
  • Ovarian Cancer
  • Carcinoma, Pancreatic
  • Renal Cell Adenocarcinoma
  • Tumors, Solid
  • Breast Cancer
  • Melanoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Pegilodecakin will improve 2 primary outcomes and 3 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of approximatley 4 months.

approximatley 4 months
Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)
up to 12 months
Anti-Pegilodecakin antibody formation
Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)
Pharmacokinetic (PK) parameters
Safety and tolerability as measured by incidence of adverse events

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

24 Treatment Groups

Part A: Dose Escalation Cohort 2
1 of 24
Part I: Dose Escalation Cohort 1
1 of 24
Part H: Dose Escalation Cohort 1
1 of 24
Part C: Dose Escalation Cohort 3
1 of 24
Part E: Dose Escalation Cohort 1
1 of 24
Part B: Dose Expansion Cohort
1 of 24
Part A: Dose Expansion Cohort 1
1 of 24
Part A: Dose Escalation Cohort 5
1 of 24
Part A: Dose Escalation Cohort 3
1 of 24
Part J: Dose Escalation Cohort 1
1 of 24
Part H: Dose Escalation Cohort 3
1 of 24
Part A: Dose Escalation Cohort 6
1 of 24
Part H: Dose Escalation Cohort 2
1 of 24
Part B: Dose Escalation Cohort 3
1 of 24
Part C: Dose Escalation Cohort 2
1 of 24
Part A: Dose Escalation Cohort 4
1 of 24
Part A: Dose Escalation Cohort 1
1 of 24
Part C: Dose Expansion Cohort 1
1 of 24
Part D: Dose Escalation Cohort 1
1 of 24
Part G: Dose Escalation Cohort 1
1 of 24
Part B: Dose Escalation Cohort 1
1 of 24
Part B: Dose Escalation Cohort 2
1 of 24
Part F: Dose Escalation Cohort 1
1 of 24
Part C: Dose Escalation Cohort 1
1 of 24
Experimental Treatment

This trial requires 350 total participants across 24 different treatment groups

This trial involves 24 different treatments. Pegilodecakin is the primary treatment being studied. Participants will be divided into 24 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.

Part A: Dose Escalation Cohort 2
Drug
Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Part I: Dose Escalation Cohort 1
Drug
Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min
Part H: Dose Escalation Cohort 1Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Part C: Dose Escalation Cohort 3Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Part E: Dose Escalation Cohort 1Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID
Part B: Dose Expansion CohortDaily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Part A: Dose Expansion Cohort 1
Drug
at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months
Part A: Dose Escalation Cohort 5
Drug
Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Part A: Dose Escalation Cohort 3
Drug
Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Part J: Dose Escalation Cohort 1
Drug
Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes
Part H: Dose Escalation Cohort 3
Drug
Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Part A: Dose Escalation Cohort 6
Drug
Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Part H: Dose Escalation Cohort 2
Drug
Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Part B: Dose Escalation Cohort 3Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Part C: Dose Escalation Cohort 2Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Part A: Dose Escalation Cohort 4
Drug
Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Part A: Dose Escalation Cohort 1
Drug
Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months
Part C: Dose Expansion Cohort 1Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Part D: Dose Escalation Cohort 1Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.
Part G: Dose Escalation Cohort 1Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD
Part B: Dose Escalation Cohort 1Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Part B: Dose Escalation Cohort 2Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Part F: Dose Escalation Cohort 1Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
Part C: Dose Escalation Cohort 1Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Pazopanib
FDA approved
Pembrolizumab
FDA approved
Pembrolizumab
FDA approved
Capecitabine
FDA approved
Interleukin-10
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies
Tumors with all histological diagnosis or tissue origin may be enrolled
Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.
Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
At least 18 years of age
Performance Status of 0 or 1
Adequate organ function

Patient Q&A Section

What is pegilodecakin?

"Pegilodecakin is similar biochemically to pefloxacin and both are active against gram negative microbes such as Pseudomonas aeruginosa. Their bactericidal action appears to be mediated, at least in part, by a reversible inhibition of cell wall synthesis." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"The cause of carcinoma, non-small-cell lung is not understood. Exposure to asbestos, tobacco, and other toxic agents in the workplace may increase the risk of developing cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, non-small-cell lung?

"Signs of metastasis of carcinoma, non-small-cell lung, in blood include high levels of lymphocytes, low serum albumin, low levels of lymphocytes with increased serum, and high levels of immunization." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

"Approximately 116,000 people will be diagnosed with carcinoma, non-small-cell lung a year in the United States in 2018. This makes up 4.8% of all new cancer diagnoses in the United States." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

"It is very difficult to attain a cure for NSCLC. Many patients survive a long time, irrespective of the stage at the time of initial detection. However, once found to have recurrent disease, patients seem to be able to cure themselves once the disease is treated for a second time. Patients with a very low number of disease recurs and a complete surgical resection of a small metastatic lesion may have a good cure, particularly if they show good response to chemotherapy at the initiation of treatment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"The first-line treatment for localized carcinoma, non-small-cell lung varies significantly among Chinese clinicians, depending largely on the degree of urgency for cure. A combination of chemotherapy, radiation therapy, and surgery, together with a few palliative measures such as topical and systemic analgesia, are recommended by most Chinese clinicians for most patients with carcinoma, non-small-cell lung." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"The prevalence of current and previous smoking is extremely high among patients with NSCLC. The prognosis and survival of patients is worse then what is expected from patients without smoking history (NSCLC). The reason of this association remains elusive and we need further investigations, including a possible epigenetic component." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, non-small-cell lung?

"The risk factors for lung cancer include tobacco smoking, air pollution, passive smoking, occupational exposure to coal dust, as well as genetics. The risk of developing lung cancer is lower than the incidence." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

"In a recent study, findings of recent studies suggest that certain subtypes of non-small-cell lung carcinoma may be responsive to novel treatments of immune checkpoint inhibitors. An update on the available evidence is included in the review." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, non-small-cell lung spread?

"For lung carcinoma, we demonstrated a significant survival difference after adjusting for differences in stage. There was no survival difference based on stage among the group with metastasis. Data from a recent study demonstrate a relationship between survival and the time to metastasis. Therefore, we suggest that the concept of occult metastasis in lung carcinoma should be reconsidered in the light of these findings." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, non-small-cell lung?

"The cancer registry data obtained by the Lung Cancer Information Exchange (LCIe) Program (http://www.federico.bnl.gov/bnl/lctu/lb/lctu/lbcic.htm) are the largest database of cancer survival rates in the world. These data indicate that the survival rate for lung cancer is approximately 17.5% for all NSCLC, 33 to 37% for stage IIIb/IV, and 32% for stages IB/IIA. The difference is less than 30% in overall survival, with a similar proportion at each stage of disease. In this registry, NSCLC survival does appear to depend on gender." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma, non-small-cell lung?

"[Men have a higher chance of developing carcinoma, non-small-cell lung than women; and, women with carcinoma, non-small-cell lung have a higher chance of developing heart disease than men]" - Anonymous Online Contributor

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