Colorectal NeoplasmsPhase 1NCT04326296
The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer
A Phase 1 study testing PD-L1 Monoclonal Antibody Combined With Lenalidomide in people with Colorectal Neoplasms, run by LiNing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- PD-L1 Monoclonal Antibody Combined With Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2020to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
- History of other malignancies 5 years ago, except for carcinoma in situ of the cervix, non-melanoma skin cancer or stage I uterine cancer
- Peripheral neuropathy of grade 2 ≥ NCI CTCAE
- Serum albumin less than 2.5g /dL
- Uncontrolled or symptomatic hypercalcemia
- Infection requiring antibiotics within 14 days prior to trial
- Chronic enteritis
- Clinically significant active gastrointestinal bleeding
- Non-diagnostic surgery within 4 weeks before the trial
- Any other disease for which there is evidence that the use of the experimental drug needs to be restricted
- Participate in other trials within 30 days prior to the trial or plan to participate in other trials during the trial
- Receive other experimental drugs within 28 days before the start of the trial
- Women who are pregnant or lactating, or who plan to become pregnant within 5 months after the end of treatment.Women of childbearing age should undergo a blood pregnancy test 7 days before the start of the trial
- Use of PD-L1 monoclonal antibody or lenalidomide contraindications
- MSI-H/dMMR in patients with advanced colorectal cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Ning Li, PhD, 0086-13526501903, lining97@126.com
Ning Li, PhD
About this study
Official title: The Safety, Tolerability and Preliminary Efficacy of PD-L1 Monoclonal Antibody Combined With Lenalidomide in Third-line Post-Treatment of Patients With Microsatellite Stable Advanced Colorectal Cancer: A Phase I Clinical Study
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.
Read the detailed description
- Phase 1 was the dose increasing phase, which was divided into three queues (A, B and C). Each team was included in the group of three people.Cohort B: pd-l1 monoclonal antibody 900mg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days;Cohort C: pd-l1 monoclonal antibody 20mg/kg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days.If none of the 3 patients in cohort A in phase 1 showed dose limited toxicity (DLT) within 21 days of their first use, they were enrolled in cohort B, and so on.If 1 of the first 3 subjects in a dose group developed DLT during the DLT observation period after the first combination administration, an additional 3 subjects were added to the dose group.If none of the additional 3 subjects developed DLT, the next incremental dose group was entered.If DLT appears in 1 or more of the additional 3 subjects, the investigator shall decide whether to adjust the regimen, or increase the regimen, or terminate the climb.If DLT appears in 2 or more subjects in the initial 3 subjects of a dose group during the observation period of the first combined DLT, the investigator shall decide whether to adjust the dosing regimen, or increase the dosing regimen, or terminate the climbing.
- In phase 2, 24 patients will be further included under the initially determined dose level and the appropriate administration regimen. Disease control rate (DCR) will be calculated according to the data obtained in phase 1, and the group with the highest DCR dose will be selected for the expansion study.
- Conditions
- Colorectal Neoplasms
- Being tested
- PD-L1 Monoclonal Antibody Combined With Lenalidomide
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 Monoclonal Antibody Combined With LenalidomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | PD-L1 Monoclonal Antibody Combined With Lenalidomide Receives: Drug: PD-L1 Monoclonal Antibody Combined With Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
It is defined as the proportion of complete response, partial response and stable disease
Measured: 1 years
Safety, Tolerability
The incidence of serious adverse events
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start30 May 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiNing
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, LiNing, Henan Cancer Hospital
- Investigators
- Ning Li, PhD, Principal investigator, Henan Cancer HospitalSuxia Luo, PhD, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326296
- Sponsor's protocol ID
- CRC202001
- Status last verified
- May 2020
- First submitted
- 26 Mar 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Tolerability and Preliminary Efficacy of PD-L1 Monoclonal Antibody Combined With Lenalidomide in Third-line Post-Treatment of Patients With Microsatellite Stable Advanced Colorectal Cancer: A Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT04326296
- Acronym / sponsor ID
- CRC202001
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- LiNingOther government
- Study start
- 30 May 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Phase 1 was the dose increasing phase, which was divided into three queues (A, B and C). Each team was included in the group of three people.Cohort B: pd-l1 monoclonal antibody 900mg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days;Cohort C: pd-l1 monoclonal antibody 20mg/kg q3w+ lenalidomide 25mg/d, administration for 21 days/discontinuation for 7 days.If none of the 3 patients in cohort A in phase 1 showed dose limited toxicity (DLT) within 21 days of their first use, they were enrolled in cohort B, and so on.If 1 of the first 3 subjects in a dose group developed DLT during the DLT observation period after the first combination administration, an additional 3 subjects were added to the dose group.If none of the additional 3 subjects developed DLT, the next incremental dose group was entered.If DLT appears in 1 or more of the additional 3 subjects, the investigator shall decide whether to adjust the regimen, or increase the regimen, or terminate the climb.If DLT appears in 2 or more subjects in the initial 3 subjects of a dose group during the observation period of the first combined DLT, the investigator shall decide whether to adjust the dosing regimen, or increase the dosing regimen, or terminate the climbing.
- In phase 2, 24 patients will be further included under the initially determined dose level and the appropriate administration regimen. Disease control rate (DCR) will be calculated according to the data obtained in phase 1, and the group with the highest DCR dose will be selected for the expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: PD-L1 Monoclonal Antibody Combined With LenalidomidePD-L1 Monoclonal Antibody Combined With Lenalidomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-L1 Monoclonal Antibody Combined With LenalidomidePD-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. | Drug | Experimental Group |
Primary outcome
Disease control rate
Time frame: 1 years
It is defined as the proportion of complete response, partial response and stable disease
Safety, Tolerability
Time frame: 1.5 years
The incidence of serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, PhD principal investigator
Henan Cancer Hospital
Suxia Luo, PhD principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PD-L1 Monoclonal Antibody Combined With Lenalidomide in people with Colorectal Neoplasms, run by LiNing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, PhD (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.