Pembrolizumab in Metastatic Anal Cancer

NCT02919969 | Completed Phase 2 Results DMC

• 1 other identifier: 16-301
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief Summary

This research study is studying a targeted therapy as a possible treatment for advanced anal cancer. The following intervention will be involved in this study:

• Pembrolizumab

Conditions

Anal Cancer

Keywords

Anal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. A complete response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)

Secondary Outcomes (4)

• PD-L1 Positive Response Rate

  36 months

• Overall Survival

  36 months

• Progression Free Survival

  36 months

• Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab

  Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment "Every 3 Weeks, from the time the informed consent is signed through 30 days following cessation of treatment

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

* Pembrolizumab is administered every 3 week intravenously * Dosage to be determine by physician

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.

Also known as: Keytruda, MK-3475

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have metastatic anal cancer that has been histologically confirmed.
• There is no limit to the number of prior therapies.
• Be willing and able to provide written informed consent/assent for the trial.
• Be ≥18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1.
• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function, all screening labs must be performed within 10 days of treatment initiation.
• Adequate Organ Function Laboratory Values
• System Laboratory Value
• Hematological
• Absolute neutrophil count (ANC) ≥1,500 /mcL
• Platelets ≥80,000 / mcL
• Hemoglobin ≥8.5 g/dL or ≥5.6 mmol/L
• Renal

You may not qualify if:

• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Subjects requiring systemic steroids are excluded from the trial. The use of physiologic doses of corticosteroids may be approved after discussion with the sponsor.
• Has a known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Note: Subjects with ≤ Grade 2 neuropathy and alopecia are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must wait ≥ 3 weeks prior to starting study treatment. They must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has an active infection requiring systemic therapy.
• Patients that require supplemental oxygen are excluded.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Results Point of Contact

• Title: James Cleary
• Organization: Dana Farber Cancer Institute

james_cleary@dfci.harvard.edu

617-632-6073

Study Officials

• James Cleary, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 30, 2016
• Study Start: October 11, 2016
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2023
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)