Pembrolizumab for Pelvic Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Pelvic Neoplasms+17 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether propranolol hydrochloride and pembrolizumab may be effective in treating urothelial cancer.

See full description

Eligible Conditions

  • Pelvic Neoplasms
  • Metastatic Ureter Urothelial Carcinoma
  • Stage IV Urethral Cancer AJCC v8
  • Locally Advanced Bladder Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Stage IV Bladder Cancer AJCC v8
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Urethral Urothelial Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Stage IV Ureter Cancer AJCC v8
  • Locally Advanced Urethral Urothelial Carcinoma
  • Locally Advanced Renal Pelvis Urothelial Carcinoma
  • Locally Advanced Ureter Urothelial Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pelvic Neoplasms

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Pelvic Neoplasms. Measurement will happen over the course of Up to 28 days.

Year 2
Immune profile and changes in selected biomarkers and cell subsets
Year 2
Progression free survival (PFS)
Year 2
Overall survival (OS)
Year 2
Overall response rate (ORR)
Up to 28 days
Incidence of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Pelvic Neoplasms

Trial Design

1 Treatment Group

Treatment (propranolol hydrochloride, pembrolizumab)
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (propranolol hydrochloride, pembrolizumab)Patients receive propranolol hydrochloride PO BID on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for propranolol hydrochloride and every 3 or 6 weeks for pembrolizumab for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Propranolol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 2 years for reporting.

Who is running the study

Principal Investigator
B. N.
Bassel Nazha, Principal Investigator
Emory University

Closest Location

Emory University Hospital/Winship Cancer Institute - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Pelvic Neoplasms or one of the other 17 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
First line: locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
Second line: locally advanced or metastatic urothelial carcinoma after progression on platinum-based chemotherapy
Patients must have measurable disease as defined by RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm (≥ 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI)
Patients must have adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator The effects of study drugs on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better

Patient Q&A Section

What is pelvic neoplasms?

"In the UK, approximately two thirds of all women (66%) have pelvic cancer which can vary in their subtype. It is the most common form of cancer in those diagnosed with pelvic (16%), perineal (12%) and anal (8%) lesions. Diagnosis of pelvic tumours can be difficult as physical symptoms are less frequent than in other organs. Surgery is the main treatment. Prophylactic treatment can reduce the amount of people who develop invasive cancers in the future." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pelvic neoplasms?

"For most patients, radical surgery with pelvic lymphadenectomy is their most common treatment mode. The surgical decision is dependent on many clinician and patient factors. If patients are diagnosed with a high-risk disease before they undergo surgery, they may require an extended adjuvant or neoadjuvant chemotherapy after surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of pelvic neoplasms?

"The absence of lower abdominal pain, pelvic mass and an ileocecal valve in a woman older than 60 years is highly suggestive of an adenocarcinoma of the endometrium, and a pelvic mass or adenocarcinoma in an elderly person without these findings suggests a non-endometrial malignancy. Other pelvic neoplasms also require imaging investigations." - Anonymous Online Contributor

Unverified Answer

What causes pelvic neoplasms?

"Pelvic neoplasms can be caused by trauma, infection, embryonal cell tumors, sarcoma, malignant melanoma, and adenocarcinoma"

"Neural cell adhesion molecule\n\nNeural cell adhesion molecule, also known as NCAM, is a multi-domain glycoprotein present on the surface of neurons and some other neuron-like cells, such as glia, that regulate axonal growth and guidance." - Anonymous Online Contributor

Unverified Answer

Can pelvic neoplasms be cured?

"The current research confirms that the incidence of neoplasms that can be cured is low. However, it does not rule out that there may be a small proportion of patients who might be able to have an enduring disease-free remission, and that further research is necessary to understand how best to treat pelvic neoplasms." - Anonymous Online Contributor

Unverified Answer

How many people get pelvic neoplasms a year in the United States?

"Around 20% of US men and 3.1% of US women develop uterine, serous, endometrioid, clear-cell carcinomatous, mucinous, or transitional cell carcinoma of the bladder a year. These cases have a mean age around 68.5 yr. More men and women were diagnosed with squamous cell carcinoma of the lung or with malignant mesothelioma around ages of 80 yr and older. There were more men than women for most urinary malignancies around aging years 70–79 yr." - Anonymous Online Contributor

Unverified Answer

Is pembrolizumab typically used in combination with any other treatments?

"There was limited information on the use of PD-1 therapy as a monotherapy or in combination with non-PD-1 agents. There was only one other study that focused on PD-1 monotherapy and was only conducted with patients newly diagnosed with metastatic melanomas." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for pelvic neoplasms?

"This analysis showed that the patients who were eligible had similar DSS than those with other eligibility requirements. Overall, the patients' baseline disease characteristics as well as age, BMI, and performance status were important in the prognosis." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing pelvic neoplasms?

"The incidence of most types of neoplasms is very low in individuals with a diagnosis of Ewing's sarcoma. The current treatment for Ewing's sarcoma consists of amputation, chemotherapy, and radiation, with a very low chance of obtaining a cure. The Ewing's sarcoma incidence rate is estimated to be two per 1,000,000 live births. The risk of developing pelvic neoplasms is estimated to be about 0.06–0.3% per year for males and about 0.1 for females. Thus the risk of developing pelvic neoplasms is 0.05–0.2% per year for both genders, and the risk is lower if men exceed 50 years of age." - Anonymous Online Contributor

Unverified Answer

Does pembrolizumab improve quality of life for those with pelvic neoplasms?

"In a recent study, findings suggest that pembrolizumab can be an effective monotherapy in treatment-naive patients with pelvic cancer and that the drug increases QOL for these patients." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pembrolizumab?

"Pembrolizumab is a well-tolerated drug which could be used even in the absence of PD-L1 expression using this drug combination. However, the small sample size and the short follow-up time could limit the impact of other potential side effects." - Anonymous Online Contributor

Unverified Answer

What does pembrolizumab usually treat?

"When utilized in a clinical setting the response rate is extremely high, with a response rate of 90% in this group of patients. The toxicity was also very limited." - 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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