Anetumab Ravtansine for Adenocarcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Colorado Hospital, Aurora, CO
Adenocarcinoma+9 More
Anetumab Ravtansine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Adenocarcinoma

Study Summary

This study is evaluating whether a combination of immunotherapy and chemotherapy may help treat pancreatic cancer.

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Eligible Conditions

  • Adenocarcinoma
  • Cancer of Pancreas
  • Stage II Pancreatic Cancer AJCC v8
  • Pancreatic Neoplasms
  • Stage IIA Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Recurrent Pancreatic Adenocarcinoma
  • Unresectable Pancreatic Carcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IIB Pancreatic Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Anetumab Ravtansine will improve 1 primary outcome and 1 secondary outcome in patients with Adenocarcinoma. Measurement will happen over the course of Up to 100 days post treatment.

Day 100
Biomarker analysis
Day 37
Maximum tolerated dose (MTD)

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Arm I (anetumab ravtansine, nivolumab)

This trial requires 74 total participants across 3 different treatment groups

This trial involves 3 different treatments. Anetumab Ravtansine is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm I (anetumab ravtansine, nivolumab)Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Arm II (anetumab ravtansine, nivolumab, ipilimumab)Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive ipilimumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of cycles 2-4. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Arm III (anetumab ravtansine, nivolumab, gemcitabine)Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive gemcitabine hydrochloride over 30-40 minutes on days 1 and 8. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30-37 days post treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30-37 days post treatment for reporting.

Closest Location

University of Colorado Hospital - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Adenocarcinoma or one of the other 9 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:
Patients with positive mesothelin expression are eligible, and this expression must be detected by a Ventana mesothelin [MSLN]- immunohistochemistry [IHC] test show original
Patients must have received and either progressed or been intolerant to at least 1 systemic therapy to be eligible for this study. show original
Irradiated lesions that progress after radiation therapy may be eligible for the study show original
At least one lesion must be accessible for biopsy; biopsies are mandatory in dose escalation and in dose expansion; in dose escalation and in expansion, the following biopsies are optional: at baseline and at progression; biopsy could be: core needle or excisional or punch biopsy show original
Patients must have archival tumor tissue for mesothelin expression and correlative biomarker studies; subjects must consent to provide tumor blocks or slides show original
The patient must have at least one measurable lesion as determined by a CT scan or MRI scan before beginning treatment show original
The sentence means that the person will live for at least 3 months. show original
Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 (Karnofsky >= 80%)
/G2 toxicity, has not been ongoing for greater than six weeks Previously treated cancer is allowed, providing the side effects of the treatment (except for hair loss) have gone away, have improved to the point where they are no longer a problem, or have only been a problem for six weeks or less. show original
and is not responsive to standard therapy People who have pancreatic cancer that is spreading (metastatic), or that can't be surgically removed (unresectable), or has come back (recurrent) after treatment, and who don't respond to standard therapy, may be eligible for this study. show original

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 are common treatments for adenocarcinoma?

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Treatment can vary due to a number of factors, including race, age, treatment type, and disease stage. Patients over age 75 should seek attention regarding the possible detrimental effects of their medications. Patients should also seek medical attention when new symptoms of disease or problems are noticed. In most cases, it is recommended that adenocarcinoma patients seek treatment at an internal medicine or oncology department. Local therapy can sometimes be carried out, depending on the stage of carcinoma, age, and the health status of the patient.

Unverified Answer

How many people get adenocarcinoma a year in the United States?

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About 75,000,000 men are diagnosed with prostate cancer each year in the United States. The number of men diagnosed with lung cancer, colorectal cancer, and pancreatic cancer are also increasing. The United States spends an annual average of $10.2 billion on health care (excluding Medicare), and Medicare spending per capita is 9.7 percent of federal spending, making this a major source of health care spending in the United States. It is clear that the demand for medical services is outrunning health system resources and that the current system of providing health care to an ever-increasing number of people will have serious consequences that we must understand to anticipate and overcome.

Unverified Answer

What causes adenocarcinoma?

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It was found that a lack of ER or pER, and high pER/ER ratio are associated with a more aggressive tumor phenotype. These are all associated with an increased incidence of ER-negative human breast tumors.

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What is adenocarcinoma?

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Adenocarcinoma encompasses tumors that include the word "adenocarcinoma" in the name. Most adenocarcinomas begin in a non-cancerous (benign) state and progress to carcinoma as they spread through the surrounding tissues to nearby areas. However, some cancers may begin in a cancerous state and remain stable (malignant) or progress (recurrent) until dying of another cause. Adenocarcinomas include many different tumors. If you hear of a tumor that has cancer in the name or if you see a solid tumor, then find out if the surgeon said the tumors appeared to be adenocarcinoma because they all have cancerous qualities.

Unverified Answer

What are the signs of adenocarcinoma?

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This report provides a comprehensive review of the presenting features of adenocarcinoma, the clinical signs and other abnormal clinical findings (such as anemia, bone pain and ocular abnormalities) that may be found when patients are admitted to the hospital with a suspicion of acute cancer or an unknown primary. This summary of clinical signs and other findings can be useful for educating the public and nurses when interpreting the clinical history and findings.

Unverified Answer

Can adenocarcinoma be cured?

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Cancers of mucosal surfaces do not always require therapy for curing. Prostate cancer is an exception. With aggressive, adjuvant therapy, the incidence of cure is over 95% among localized, high-grade, stage T1-T3 cancers.

Unverified Answer

How does anetumab ravtansine work?

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These data support both the anti-MMA2 and anti-CD20 mechanisms of action of anetumab and support further clinical exploration of anetumab as a potential immune checkpoint inhibitor for cancers which overexpress CD20+ B cells or which express high amounts of MAM1 protein.

Unverified Answer

Is anetumab ravtansine safe for people?

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The most common side effects with anetumab ravtansine were fatigue and rash (22 and 24%, respectively). All side effects were non-serious and manageable, and manageable discontinuation rates were >88%.

Unverified Answer

Does anetumab ravtansine improve quality of life for those with adenocarcinoma?

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Anetumab ravtansine substantially improved quality of life and resulted in better tolerability and compliance during the Phase III trial than both chemotherapy and observation in patients with metastatic adenocarcinoma of the peritoneum.

Unverified Answer

What are the latest developments in anetumab ravtansine for therapeutic use?

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the anetumab ravtansine demonstrates substantial antitumor activity, with good safety and tolerability profiles with preliminary evidence of significant clinical antifibrotic activity. Clinical trials are ongoing globally.

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Has anetumab ravtansine proven to be more effective than a placebo?

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Anetumab ravtansine significantly improved OS in this second phase II trial versus a placebo in patients with metastatic metastatic colorectal cancer. The data demonstrate that the investigational combination is more effective than standard of care. Patients with a PD-1 or PD-L1 mutation (or both) were shown to have a partial response to anetumab ravtansine and improved OS relative to the patients not expressing any of these biomarkers.

Unverified Answer

What is the primary cause of adenocarcinoma?

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Tobacco tobacco was the most common presenting risk factor for AADC. The incidence of squamous cell carcinoma was also significantly increased. Other factors could be involved, in addition to the effect of tobacco alone.

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