Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Capecitabine

Durvalumab

Iron-Dextran Complex

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks (colorectal cancer patients only)

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

CV301

1000mg orally twice a day, Monday - Friday Weekly

Michael Pishvaian, MD PhD

This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination With Maintenance Chemotherapy for Patients With Metastatic Colorectal or Pancreatic Adenocarcinoma

The Recommended Phase II dose of durvalumab in the combination of durvalumab plus CV301 with maintenance chemotherapy as determined by the Phase I design

To determine the progression free survival (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine and bevacizumab in patients with metastatic colorectal cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

To determine the progression free survival rate (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine in patients with metastatic pancreatic cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

ORR is defined as the proportion of patients whose best overall response recorded during treatment is either CR or PR according to the RECIST version 1.1.

PFS is defined as the time from consenting to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.

To determine overall survival, subjects will be followed from time of consent until death (or until study termination). Subject will be followed for survival after discontinuing study medication and after the adverse event collection period has ended.

DCR is defined as the proportion of patients with a documented CR, PR, or SD at 4 months according to the RECIST version 1.1.

Tolerability and safety of the combination as determined by the number of patients with treatment emergent adverse events

The duration of response will also be captured as the time from which a response was first identified, until progression of disease according to the RECIST version 1.1 (or death due to any cause).

Mayo Clinic

Indiana University

Emory University

National Cancer Institute (NCI)

George Mason University

Thomas Jefferson University

MedImmune LLC

Bavarian Nordic

Georgetown University

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks (colorectal cancer patients only)

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly

Bevacizumab: 5mg/kg IV q2weeks

Phase I - Safety

Phase I - Safety- All Groups

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Benjamin Weinberg, MD

Phase 1 not completed because study terminated due to lack of enrollment. Recommended phase II dose could not be determined.

Recommended Phase II Dose of Durvalumab

Phase I - Safety- Colorectal Cancer

Progression Free Survival (PFS) Colorectal Cancer

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.

Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly

Phase I - Safety- Pancreatic Cancer

Progression Free Survival (PFS) Pancreatic Cancer

Objective Response Rate (ORR)

Phase I - Safety- Overall

Progression Free Survival (PFS)

number of subjects still alive at the end of the study follow up

Overall Survival (OS)

Disease Control Rate (DCR)

Tolerability and Safety of the Combination

Duration of Response

Phase I - Safety- Colorectal Cancer Arm

* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly

Durvalumab: 750mg IV q2 weeks

CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)

FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5mL given s.c.

Capecitabine: 1000mg orally twice a day,Monday - Friday Weekly

Phase I - Safety- Pancreatic Cancer Arm

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antibodies

Antibodies, Monoclonal

Vaccines

Immunomodulating Agents

Immunoglobulins

Surveillance followed by Prostvac + CV301 then Prostvac + CV301 + MSB0011359C

Surveillance as needed followed by Prostvac + CV301

Recombinant vaccinia virus vector vaccine of the genus Orthopoxvirus. Administered by subcutaneous injection.

PROSTVAC-V

Recombinant fowlpox virus vector vaccine of the genus Avipoxvirus. Administered by subcutaneous injection.

PROSTVAC-F

Fully human bifunctional fusion protein that combines IgG1 anti-PD-L1 and TGFbetaRII as a monoclonal antibody. Administered via IV infusion over 1 hour.

MSB0011359C (M7824)

Recombinant vaccinia virus vaccine of the genus Avipoxvirus. Administered subcutaneously.

Ravi A Madan, M.D.

Background:

Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people.

Objective:

To see if the combination treatment of PROSTVAC, CV301, and MSB0011359C (M7824) can induce an anti-tumor attack in people with biochemically recurrent prostate cancer.

Eligibility:

People ages 18 and older with certain kinds of prostate cancer

Design:

Participants will be screened with

* Medical history
* Physical exam
* Blood and urine tests
* A scan of the neck, chest, abdomen, and pelvis
* A bone scan

A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status.

Some participants will have close monitoring with four monthly PSA checks.

All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after.

Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans.

Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.

Background:

Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (i.e., biochemically recurrent \[BCR\] prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.

ADT can lower the PSA in these patients, but because of its substantial side effect profile and ambiguous long-term impact, it is generally deferred by most patients until there is a rapid escalation in their PSA.

Immunotherapy presents an alternative option for these patients that is especially attractive because it is not associated with substantial toxicity. Also, since immunotherapy can have lasting effects after treatment due to a sustained activated immune response, patients will not be required to take these treatments indefinitely to potentially benefit clinically.

Current and previous clinical trials have demonstrated that single agent immunotherapy can impact PSA in patients in this population.

The focus of this study is to determine if combination immunotherapy with immune-cell mobilizing vaccines can initiate an immune response in the first 4 months that is then augmented by an immune checkpoint inhibitor in the following 3 months.

In addition to PSA responses (the primary metric in this population), safety, changes in immune responses, and PSA kinetics will also be evaluated.

Objectives:

Primary Objectives:

Safety Lead-In: To evaluate the safety and tolerability of combination immunotherapy in participants with castration-resistant prostate cancer

Biochemical Recurrence: To determine if the combination immunotherapy can induce a 30% decline in PSA in 28% of participants with biochemically recurrent prostate cancer.

Eligibility Criteria (for biochemical recurrence):

Histologically confirmed adenocarcinoma of the prostate

Participants with negative CT Scan and Tc-99m Bone Scan

Participants with a PSA over 0.8 ng/ml for participants following radical prostatectomy or for participants following definitive radiation therapy: a rise in PSA of \>= 2 ng/mL above the nadir

Participants with a PSA doubling time of 5-15 months

No history of active autoimmune disease or history of organ compromising autoimmune disease

ECOG 0-1

Safety lead-in cohort will evaluate 6 participants with castration resistant prostate cancer

Design:

Three-arm, non-randomized study

Accrual goal is a total of 37 evaluable participants (6 in an initial safety cohort, 6 participants who received M7824 as part of the initial investigation and 25 homogenously treated participants) to evaluate response

Participants from an on-going study (NCT02649439) with nearly identical eligibility can serve as a contemporary control for secondary endpoints

Following the safety lead-in, all participants will be enrolled and may undergo a surveillance period during which up to 4 consecutive monthly PSA values will be captured by the labs.

After surveillance period, if applicable, participants will be treated with 2 vaccines concurrently, Prostvac and CV301, during months 1-4. For months 5-7, MSB0011359C \[an anti-PD-L1 antibody (avelumab) with TGF(Beta)-Trap molecule\] will be added to the regimen.

-Effective with amendment v7/29/2021, MSB0011359C will no longer be given as part of the treatment combination for the Biochemical Recurrence cohort (Arms 2 and 3)

Participants will be monitored for on-treatment and post-treatment PSA, immune and imaging responses.

Combination Immunotherapy in Biochemically Recurrent Prostate Cancer

Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

fraction of evaluable subjects who experience at least a 30% decline from the maximum to the minimum PSA value while on study

The slopes obtained after administering the vaccines alone or in combination with the checkpoint inhibitor will be tested vs the slopes obtained prior to administering the vaccines, using a two-tailed 0.05 significance level paired t-test or Wilcoxon signed rank test (if the paired differences are not normally distributed)

Reprting the grade of adverse events noted in each participant and reporting the fraction with grade 3 and grade 4 adverse events

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pembrolizumab

Nivolumab

Immune Checkpoint Inhibitors

CV301 + Pembrolizumab (Phase 1b portion of the trial)

CV301 + Nivolumab (Phase 1b portion of the trial)

Cesar Pico-Navarro, MD

The objective of the proposed clinical trial is to investigate the safety and tolerability of CV301 in combination with Anti-PD1-Therapy in subjects with non-small cell lung cancer (NSCLC).

The clinical trial is designed to evaluate the possible enhanced antitumor activity of CV301 with Anti-PD1-Therapy. The rationale for combining CV301 with Anti-PD1-Therapy is based on the hypothesis that CV301 can induce specific immune response in the tumor, and that in combination, Anti-PD1-Therapy may augment the T cell-mediated immune response generated by CV301 by blocking the inhibitory signal of the PD-1.

The trial will include a Phase 1 portion and a Phase 1b portion with 2 cohorts. The Phase 1 portion is a dose escalation part to assess the safety and tolerability of CV301 alone, prior to moving into the combination with Anti-PD1-Therapy (the Phase 1b component).

The following Phase 1b portion of the trial aims to test the safety and tolerability of the combination treatment using a two cohort approach with cohort 1 receiving CV301 plus Nivolumab and cohort 2 receiving CV301 plus Pembrolizumab.

A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

Safety and tolerability following administration of CV301 alone (Phase 1) and in combination with Nivolumab or Pembrolizumab (Phase 1b), respectively, as determined by the incidence of dose-limiting toxicities (DLTs).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma	NCT03376659	Metastatic Colo... Colorectal Aden... Pancreatic Aden... Metastatic Panc...	Durvalumab CV301 Capecitabine Bevacizumab	18 Years -	Georgetown University
Combination Immunotherapy in Biochemically Recurrent Prostate Cancer	NCT03315871	Prostate Cancer	PROSTVAC-V PROSTVAC-F MSB0011359C (M7... CV301	18 Years -	National Institutes of Health Clinical Center (CC)
A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer	NCT02840994	Non-small Cell ...	CV301 Pembrolizumab Nivolumab	18 Years -	Bavarian Nordic
A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer	NCT02840994	Non-small Cell ...	CV301 Pembrolizumab Nivolumab	18 Years -	Bavarian Nordic

Spots Global Cancer Trial Database for cv301

Every month we try and update this database with for cv301 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cv301

Every month we try and update this database with for cv301 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cv301 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.