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Hodgkin Lymphoma, AdultPhase 2NCT03155425

PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma

A Phase 2 study testing SHR-1210 in people with Hodgkin Lymphoma, Adult, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma, Adult
What is being tested?
SHR-1210
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesChina
Study dates
9 Jun 2017to 30 Sep 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed classic Hodgkin's lymphoma;
  • Relapsed or refractory cHL and meet any of the following criterions: a) did not achieve remission or progression after autologous hematopoietic stem cell transplantation. b) at least 2 lines of systemic chemotherapy and are not suitable for autologous stem cell transplantation;
  • Subjects enrolled have measurable lesion (s) according to Lugano 2014 criteria;
  • ECOG performance status of 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • Adequate laboratory parameters during the screening period as evidenced by the following:
Show all 14Show fewer
  • Absolute neutrophil count ≥ 1.0 × 109/L;
  • Platelets ≥ 75 × 109/L;
  • Hemoglobin ≥ 8.0 g/dL;
  • Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN;
  • Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
  • Coagulation function index: INR ≤1.5×ULN，APTT≤1.5×ULN;
  • Women of childbearing potential (WOCBP) must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7 days before entering the group; male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment;
  • Able to understand and sign an informed consent form (ICF).

Who cannot join

  • Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma.
  • Known central nervous system lymphoma.
  • History and complication:
  • Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted; (2) Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10mg; doses > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group; (3) Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose SHR-1210; (4) Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody; (5) Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; (6) Known and highly Suspicion of interstitial pneumonia; (7) Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded); (8) Received chemotherapy, radiotherapy, immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1; (9) Prior allo-HSCT; (10) ASCT within 90 days; (11) Impact of major surgery or severe trauma had been eliminated for less than 14 days; (12) Active pulmonary tuberculosis; (13) Severe acute or chronic infection requiring systemic therapy; (14) Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment. Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months; (15) Inoculated with live vaccine within 4 weeks before receiving the investigational drug. Injections of inactivated influenza vaccine for seasonal influenza are permitted, but not live attenuated influenza vaccines for intranasal use.
  • 4. laboratory test:
  • known HIV positive or known AIDS; (2) Untreated active hepatitis; co-infection with hepatitis B and hepatitis C.
  • 5. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Classic Hodgkin's Lymphoma

This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma.

Read the detailed description

The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in relapsed or refractory classic Hodgkin's lymphoma. Pharmacokinetic index is also investigated in 12 patients.

Being tested
SHR-1210
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    A humanized monoclonal immunoglobulin

Study groups in NCT03155425
Study groupRoleWhat they receive
Injection SHR-1210ExperimentalSHR-1210 injection, 200 mg/dose, intravenous infusion.
Receives: Drug: SHR-1210

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR Assess by IRC

    rate of subjects achieved complete response plus partial response in all evaluable subjects (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR)

    Measured: CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported.

Secondary outcomes (5)

  1. DoR Assess by IRC

    Duration of Response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm，or appearance of new lesions, or progression of non-target lesion )

    Measured: CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. DoR of 36 weeks based on CT and PET were reported.

  2. PFS Assess by IRC

    Progression-free Survival (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, disease progression is over 50% increase of an product of perpendicular diameters of any target lesion from nadir with any diameter increased over 0.5cm for lesions <=2cm or increased by 1cm for lesions >2cm，or appearance of new lesions, or progression of non-target lesion )

    Measured: Up to 3 years

  3. TTR Assess by IRC

    Time to response (Response was assessed with CT and PET using 2014 Lugano Criteria for Malignant Lymphomas, CR is disappearance of all tumor lesions, PR is over 50% decrease of the sum of the product of the perpendicular diameters from baseline ;overall response:PR+CR)

    Measured: CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25.

  4. OS

    Overall Survival

    Measured: Up to 3 years

  5. Incidence and Severity of Adverse Events (AE)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start9 Jun 2017
  3. Primary completion31 Aug 2020
  4. Study completion30 Sep 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155425
Sponsor's protocol ID
SHR-1210-II-204
Status last verified
Apr 2023
First submitted
15 May 2017
Last updated
1 Feb 2024
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Song Y, Wu J, Chen X, Lin T, Cao J, Liu Y, Zhao Y, Jin J, Huang H, Hu J, Luo J, Zhang L, Xue H, Zhang Q, Wang W, Chen C, Feng J, Zhu J. A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma. Clin Cancer Res. 2019 Dec 15;25(24):7363-7369. doi: 10.1158/1078-0432.CCR-19-1680. Epub 2019 Aug 16.

    PubMed 31420358

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 in people with Hodgkin Lymphoma, Adult, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 7 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR Assess by IRC (time frame: CT was conducted at baseline, at weeks 9, 17, 25, 37, 49, 65, 81, and 97, and then every 26 weeks; PET was conducted at baseline, weeks 17 and 25. ORR of 36 weeks based on CT and PET were reported.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155425, which also lists 1 linked publication.

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 1 Feb 2024.

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