The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer

NCT04326296 | Unknown Phase 1

• 1 other identifier: CRC202001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposed by increasing dosage and expand the "3 + 3" queue, main component is divided into two phases, phase 1 for dose escalation, according to preliminary data recommended doses starting dose of climbing, the purpose is to evaluate the safety of combination therapy, tolerance, and explore the maximum tolerated dose (MTD) and right dose recommended development stage;Phase 2 was the expansion phase. Patients were included in the expansion study according to the appropriate dose recommended in phase 1, to further evaluate the safety and tolerability of combination therapy, recommend appropriate dose for phase II clinical trial, and preliminarily explore the efficacy of combination therapy.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Disease control rate

  It is defined as the proportion of complete response, partial response and stable disease

  1 years

• Safety, Tolerability

  The incidence of serious adverse events

  1.5 years

Study Arms (1)

Experimental Group

EXPERIMENTAL

PD-L1 Monoclonal Antibody Combined With Lenalidomide

Drug: PD-L1 Monoclonal Antibody Combined With Lenalidomide

Interventions

PD-L1 Monoclonal Antibody Combined With Lenalidomide DRUG

PD-L1 monoclonal antibody was administered by intravenous drip every 3 weeks.Lenalidomide was administered orally, 25mg once a day on days 1-21 of each repeat cycle of 28 days.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aigned informed consent
• Only patients aged 18-75 years were enrolled
• Patients with advanced colorectal cancer diagnosed by pathology and imaging.Note: the presence of distant metastases should be confirmed by a CT or MR scan.Bone scan should be performed if bone metastases are suspected.Local radiotherapy for pain relief is permitted for bone metastases.
• Measurable lesions based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 must be present.Local radiotherapy of target lesions is not allowed.
• pMMR/MSS advanced colorectal cancer patients with disease progression or intolerance to third-line treatment after failure of current standard third-line treatment
• ECOG 1 minute or less
• Tumor specimens that can be used to detect the status of pd-l1, MSI, b-raf and k-ras can be provided.This test requires the patient to provide paraffin embedded biopsy specimens or white slices.
• White blood cells ≥ 4×109/L, platelets ≥ 100×109/L without transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without treatment with granulocyte stimulating factor, and hemoglobin ≥ 90 g/L.
• Bilirubin ≤ 1.5 times of the upper limit of normal value, and cereal grass and cereal propyl transaminase ≤ 2.5 times of the upper limit of normal value.
• Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45 ml/min
• Serum albumin ≥ 25 g/L (2.5g /dL)
• INR or APTT ≤ 1.5 times ULN
• Hepatitis B/C surface antigen positive patients need to be tested for Hepatitis B /C virus DNA quantitative test, only \< the upper limit of the normal detection value can be included in the group, and long-term use of anti-hb/hc drugs
• Drug elution time: 28 days or 5 half-lives from the last drug application.

You may not qualify if:

• Allergy to any experimental drug or its excipients, or history of severe allergy, or contraindication to the experimental drug
• Having a history of autoimmune disease or being active
• Previous allogeneic bone marrow transplantation or organ transplantation
• Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia
• HIV positive
• Active Hepatitis B /C(Hepatitis B /C viruses have higher quantification than normal)
• Active stage tuberculosis
• Uncontrolled cancer pain
• A live attenuated vaccine was injected within 4 weeks before the study began, or a live attenuated vaccine is expected to be injected during the trial or within 5 months after the end of the trial
• Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PD-L1 monoclonal antibody
• CT indicates lung active inflammation
• Systemic administration of glucocorticoids or immunosuppressants within 2 weeks prior to the trial.Inhaled corticosteroids and halocorticoids are allowed
• Use of hormones is contraindicated
• Serious cardiovascular disease, myocardial infection, arteriovenous thrombosis or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
• Uncontrollable increase in blood pressure or blood sugar

Sponsors & Collaborators

• LiNing: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ning Li, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Suxia Luo, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, PhD

CONTACT

13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: May 30, 2020
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

CN (1)