Actively Recruiting
A Phase 2b, Open-label, Randomized Study of DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Led by ImmunoVaccine Technologies, Inc. (IMV Inc.) ยท Updated on 2023-04-07
102
Participants Needed
50
Research Sites
26 weeks
Total Duration
On this page
Sponsors
I
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide (CPA), in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.). Participants will be randomly assigned to one of two groups: one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants' health and treatment effects over time.
CONDITIONS
Brief Title
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older who can provide written informed consent
- ECOG performance status of 1 or less; status 2 may be allowed with Medical Monitor approval
- Pathologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), including specific subtypes
- Progressive disease after at least two prior systemic therapies including an anthracycline and rituximab or similar agent
- Failed or ineligible for autologous stem cell transplant (ASCT) or CAR-T therapy
- At least one measurable lesion according to Lugano 2014 criteria
- Willing to provide tumor biopsy tissue before and during treatment
- Meet specific laboratory requirements
- Life expectancy greater than 3 months
You will not qualify if you...
- Primary central nervous system lymphoma or active secondary CNS involvement or lymphomatous meningitis
- Chemotherapy, immunotherapy, major surgery, or investigational treatment within 28 days before Day 0 or 5 half-lives, whichever is shorter
- Radiotherapy within 14 days before Day 0
- Autologous stem cell transplant within 100 days before Day 0
- CAR-T therapy within 28 days before Day 0
- Immunodeficiency disorder or active autoimmune disease requiring systemic treatment in the past 2 years
- Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be allowed)
- Prior malignancy other than eligible lymphoma subtypes unless disease free for 2 or more years
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive DPX-Survivac injections, pembrolizumab infusions, and, if assigned, intermittent low-dose cyclophosphamide according to their randomized arm.
Pembrolizumab IV infusions every 3 weeks; DPX-Survivac SC injections on Day 7, Day 28, then every 8 weeks; cyclophosphamide taken orally 7 days on and 7 days off for Arm 1
Trial Site Locations
Total: 50 locations
1
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States, 92708
Actively Recruiting
2
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Withdrawn
3
BRCR Medical Center Inc.
Hollywood, Florida, United States, 33021
Withdrawn
4
BRCR Medical Center Inc.
Plantation, Florida, United States, 33322
Withdrawn
5
Comprehensive Hematology and Oncology
St. Petersburg, Florida, United States, 33709
Withdrawn
6
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States, 70112
Actively Recruiting
9
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
10
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
11
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
12
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Withdrawn
13
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Withdrawn
14
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
Actively Recruiting
15
Allegheny Health Network (AHN) West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
16
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
17
Prairie Lakes Health Care System
Watertown, South Dakota, United States, 57201
Withdrawn
18
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
19
Epworth Freemasons Hospital
Melbourne, Victoria, Australia, 3002
Actively Recruiting
20
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Actively Recruiting
21
Westmead Hospital
Westmead, Australia, 2145
Actively Recruiting
22
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7H 4H4
Actively Recruiting
23
Hรดpital Avicenne
Bobigny, France, 93000
Actively Recruiting
24
Centre d'Oncologie de Gentilly
Nancy, France, 54000
Actively Recruiting
25
Hรดpital Privรฉ du Confluent
Nantes, France, 44277
Actively Recruiting
26
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
27
Hรดpital Saint-Antoine
Paris, France, 75012
Actively Recruiting
28
Hรดpital de la Pitiรฉ-Salpรชtriรจre
Paris, France, 75013
Actively Recruiting
29
Hรดpital Necker
Paris, France, 75015
Actively Recruiting
30
CHU Bordeaux- Hรดpital Haut Lรฉvรชque
Pessac, France, 33600
Actively Recruiting
31
Centre Hospitalier de Pรฉrigueux
Pรฉrigueux, France, 24019
Actively Recruiting
32
Centre Hospitalier de Saint-Quentin
Saint-Quentin, France, 02321
Actively Recruiting
33
Debreceni Egyetem Klinikai Kรถzpont
Debrecen, Hungary, 4032
Actively Recruiting
34
SzSzBM Korhazak es Egyetemi Oktatokorhaz
Nyรญregyhรกza, Hungary, 4400
Actively Recruiting
35
North Shore Hospital
Auckland, Auckland Province, New Zealand, 0622
Actively Recruiting
36
Palmerston North Hospital
Palmerston North, Manawatu, New Zealand, 4414
Actively Recruiting
37
Szpitale Pomorskie Sp. z o. o.
Gdynia, Poland, 85-519
Actively Recruiting
38
Wojewรณdzki Szpital Specjalistyczny w Legnicy
Legnica, Poland, 59-220
Actively Recruiting
39
SP ZOZ MSWiA z Warmiลsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland, 10-228
Actively Recruiting
40
Centrum Medyczne Pratia Poznaล
Skรณrzewo, Poland, 60-185
Actively Recruiting
41
Narodowy Instytut Onkologii im. Marii, Skลodowskiej-Curie
Warsaw, Poland, 02-781
Actively Recruiting
42
Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"
Bucharest, Romania, 022328
Actively Recruiting
43
The Oncology Institute "Prof. Dr. Ion Chiricuลฃฤ" I.O.C.H.
Cluj-Napoca, Romania, 400015
Actively Recruiting
44
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
45
Oncology Institute of Vojvodina
Kamenitz, Serbia, 21204
Actively Recruiting
46
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
47
Clinical Hospital Center Zemun
Zemun, Serbia, 11080
Actively Recruiting
48
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
49
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
50
Hospital Universitario Virgen del Rocรญo
Seville, Spain, 41013
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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