A Phase 2 interventional study of Pembrolizumab and paricalcitol in Pancreatic Cancer, Pancreas Adenocarcinoma and Advanced Pancreatic Cancer, sponsored by Translational Genomics Research Institute. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by Translational Genomics Research Institute · Phase 2, Interventional, and Treatment
Among 1,852 studies in Pancreatic Neoplasms with a site in United States — 303 open to participants now, 475 under way, 25 of them phase 3. Pancreatic Neoplasms · United States.
Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, this one is the 988th largest by enrollment of the 1,575 interventional ones that give a count, is one of 101 that started in 2017, is one of 488 in phase 2, and was the 1,105th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →303 of the 1,852 studies in Pancreatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Anova Innovation Limited · Sites in United States
IMGT Co., Ltd. · Sites in United States, Korea, Republic of
AdventHealth · Sites in United States
Pfizer · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,852 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 779 · Phase 2 722 · Phase 3 91 · Phase 4 12
First in 1991; this study’s year is marked. 101 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 37 across the 1,575 interventional studies, 137 across the 230 observational. Of the 1,219 that completed or were terminated, 478 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
578 of 1,852 have an industry lead sponsor. The 10 most frequent:
Translational Genomics Research Institute is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Translational Genomics Research Institute has 1 study filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
164 of the studies in Pancreatic Neoplasms with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05720338Phase 3Case Comprehensive Cancer CenterIs Intraperitoneal Drainage Necessary Following Distal Pancreatectomy? | 2026-12-31 |
| NCT03257033Phase 3RenovoRxIntra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC | 2027-06 |
| NCT06861088Phase 3Quercis Pharma AGThe Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer | 2027-10-31 |
| NCT04275557H. Lee Moffitt Cancer Center and Research InstituteUsing Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas | 2026-11 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
Among the 1,852 studies in Pancreatic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chemotherapy regimens for pancreatic cancer can now stabilize a patient's cancer and/or place some patients in remission or partial remission. The challenge now is to find options for maintenance therapies that will improve survival and allow continued benefits with minimal toxicities and inconvenience to the patients. This study will determine the effects of one possible maintenance regimen.
The study is being conducted to determine the effects that pembrolizumab with or without the addition of paricalcitol may have on pancreatic cancer. Half of the patients will be randomized to receive pembrolizumab + paricalcitol and half to receive pembrolizumab + placebo.
Pembrolizumab (also known as Keytruda®), which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but has not been approved to treat pancreatic cancer. Pembrolizumab helps the body detect and fight cancer by making cancer cells more vulnerable to attack by the body's immune system. This medication binds to and lessens the action of specific parts of cells in the body's immune system, which act to modulate or balance the immune response. By decreasing this modulation of the immune response, the body's own system may be better able to fight the cancer. Pembrolizumab is known as an immune checkpoint inhibitor.
It is thought that the effect of pembrolizumab could possibly be strengthened by the addition of paricalcitol, which is a form of vitamin D. Paricalcitol may make the cells in the immune system more sensitive to the activity of pembrolizumab and could make the local environment hostile to the cancer cells. Both activities could be effective against cancer growth.
Paricalcitol (also known as Zemplar®) is used to treat high levels of parathyroid hormone and prevent bone loss in patients with advanced kidney disease. Paricalcitol is not approved by the FDA for the treatment of advanced pancreatic cancer.
The effects of the study drugs will be assessed by repeated radiological imaging (CT scans), incidence of adverse reactions, and survival rates.
Participants will also be asked to provide biological specimens for the study team to measure cellular changes. This will include fecal matter (stool), blood, and tumor tissue.
The Food and Drug Administration (FDA) has determined that this study meets the requirements for Investigational New Drug (IND) Exemption.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A female participant is eligible to participate if she is not pregnant , not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) as defined in protocol
OR
Exclusion Criteria:
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle1/ Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent(s).
Note: Patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the trial.
Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has a known history of or is positive for (e.g., HBsAg reactive) or virus (e.g., HCV RNA [qualitative] is detected).
Note: Without known history testing needs to be performed to determine eligibility.
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week
Drug: Pembrolizumab · Drug: paricalcitol
pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week
Drug: Pembrolizumab · Drug: placebo
pembrolizumab solution for infusion
Also known as: Keytruda
Paricalcitol solution for injection
Also known as: Zemplar
normal saline solution for injection
Also known as: placebo for paricalcitol
Progression- Free Survival at 6 Months From Initiation of Trial Treatment
Progression Free Survival (PFS) defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) survival in the absence of death or progressive disease which is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: 6 months from trial treatment initiation cycle 1/day 1. Each treatment cycle is 21 days.
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment.
All adverse events occurring on or after Cycle 1/day 1through 30 days after the last dose of trial treatment will be summarized by body systems and per grade according to NCI-CTCAE Version 4.
Time frame: initiation of trial treatment cycle 1/day 1 through 30 days after last dose of trial treatment. Each treatment cycle is 21 days.
Difference in Overall Survival (OS) in Patients Administered the Combination of Paricalcitol Plus Pembrolizumab Versus Pembrolizumab Alone
Duration of survival will be defined as the time from initial treatment (cycle1/day1) until death. Overall survival will be estimated for each arm using a Kaplan-Meier estimate.
Time frame: From date of treatment initiation cycle 1/day 1 until death from any cause, assessed up to 24 months ( the end of the study).
Change in Tumor Mutational Landscape and Transcriptional Programs Using Unbiased Genome-wide Sequencing
Mutational landscapes, transcriptional programs in tumor tissue
Time frame: Optional tumor biopsy taken at baseline and at 9 +/- 1 week following initiation of treatment
Cellular VDR Targets in the Immune Microenvironment With PD1 Blockade
Identify cellular VDR targets in the immune microenvironment
Time frame: From baseline, at 9 +/- 1 week following initiation of treatment, at the time of confirmed response, and at the time of trial treatment discontinuation for any reason, up to 24 months ( 35 treatment cycles).
Exploratory: Difference in Disease Progression According to RECIST 1.1 and iRECIST
Difference in disease progression according to RECIST 1.1 and iRECIST criteria
Time frame: tumor assessments performed every 9 +/- 1 week while on treatment, up to 24 months.
Exploratory: Utility of a Patient Personalized Clinical Benefit (PPCB) Phone Based Application
Patient compliance rate of completing the PPCB application was calculated by the total percentage of completed questionnaires over expected questionnaires across all participants.
Time frame: From baseline, patients will complete the PPCB App weekly during trial treatment, and at the time of trial treatment discontinuation for any reason, assessed up to 24 months (35 treatment cycles).Each treatment cycle is 21 days.
Exploratory:Improvement in Symptoms as Recorded by the Patient Personalized Clinical Benefit (PPCB) With Progression at 6 Months by RECIST 1.1
Improvement in symptoms as recorded by the Patient Personalized Clinical Benefit (PPCB)
Time frame: From baseline, patients will complete the PPCB App weekly during trial treatment, and at the time of trial treatment discontinuation for any reason, assessed up to 24 months (35 treatment cycles). Each treatment cycle is 21 days.
Changes in Tumor and/or Tissue Texture on Imaging in Both Arms of the Trial Using Quantitative Textural Analysis (QTA)
Differences in tumor and/or tissue texture on CT scans between the two treatment arms
Time frame: tumor assessments performed every 9 +/- 1 week while on treatment, up to 24 months.
Exploratory: Monitor and Compare the Gut Microbial Communities in Both Arms of the Trial
Differences in gut microbial communities within and between fecal samples using alpha and beta diversity metrics based on 16S rRNA sequencing
Time frame: Fecal swab samples collected pre and post dose day 1 of each cycle, up to 35 treatment cycles. Each treatment cycle is 21 days.
| Milestone | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Started | 12 | 12 |
| Completed | 9 | 12 |
| Not completed | 3 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Death | 1 | 0 |
Progression Free Survival (PFS) defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) survival in the absence of death or progressive disease which is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
| Participants | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Progression- Free Survival at 6 Months From Initiation of Trial Treatment | 0 | 2 |
All adverse events occurring on or after Cycle 1/day 1through 30 days after the last dose of trial treatment will be summarized by body systems and per grade according to NCI-CTCAE Version 4.
| Participants | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Abdominal bloating | 1 | 0 |
| Abdominal pain | 1 | 2 |
| ALT increase | 2 | 0 |
| Alkaline phosphatase increase | 1 | 0 |
| Anemia | 0 | 1 |
| Arthralgia | 2 | 0 |
| AST increase | 2 | 1 |
| Creatinine increase | 2 | 0 |
| Hypertension | 0 | 2 |
| Hypophysitis | 1 | 0 |
| Nausea | 1 | 0 |
| Pruritis | 1 | 0 |
| Uticaria | 0 | 1 |
| Vomiting | 1 | 0 |
Duration of survival will be defined as the time from initial treatment (cycle1/day1) until death. Overall survival will be estimated for each arm using a Kaplan-Meier estimate.
| months | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Difference in Overall Survival (OS) in Patients Administered the Combination of Paricalcitol Plus Pembrolizumab Versus Pembrolizumab Alone | 10.4 (2.9 to NA) | NA (2.5 to NA) |
Mutational landscapes, transcriptional programs in tumor tissue
No measurements were reported for this outcome.
Identify cellular VDR targets in the immune microenvironment
No measurements were reported for this outcome.
Difference in disease progression according to RECIST 1.1 and iRECIST criteria
No measurements were reported for this outcome.
Patient compliance rate of completing the PPCB application was calculated by the total percentage of completed questionnaires over expected questionnaires across all participants.
| % of questionnaires completed | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Exploratory: Utility of a Patient Personalized Clinical Benefit (PPCB) Phone Based Application | 89.4 | 92.8 |
Improvement in symptoms as recorded by the Patient Personalized Clinical Benefit (PPCB)
| Participants | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Improvement in symptoms | 8 | 7 |
| Worsening in symptoms | 4 | 3 |
| No change in symptoms | 0 | 2 |
Differences in tumor and/or tissue texture on CT scans between the two treatment arms
No measurements were reported for this outcome.
Differences in gut microbial communities within and between fecal samples using alpha and beta diversity metrics based on 16S rRNA sequencing
No measurements were reported for this outcome.
Collected over Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab & Paricalcitol | 8/12 (66.7%) | 4/12 (33.3%) | 12/12 (100%) |
| Pembrolizumab & Placebo | 4/12 (33.3%) | 4/12 (33.3%) | 12/12 (100%) |
| Event | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| Malignant Neoplasms- Squamous Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/12 | 2/12 |
| Blood bilirubin increasedInvestigations | 0/12 | 1/12 |
| Renal and urinary disorders - Other, hepatorenal syndromeRenal and urinary disorders | 1/12 | 0/12 |
| Myocardial infarctionCardiac disorders | 1/12 | 0/12 |
| Cardiac disorders - Other, takotsubo cardiomyopathyCardiac disorders | 1/12 | 0/12 |
| Abdominal painGastrointestinal disorders | 1/12 | 1/12 |
| VomitingGastrointestinal disorders | 1/12 | 0/12 |
| Obstruction gastricGastrointestinal disorders | 1/12 | 0/12 |
| SepsisInfections and infestations | 1/12 | 0/12 |
| Abdominal infectionInfections and infestations | 1/12 | 0/12 |
| Event | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 5/12 | 3/12 |
| NauseaGastrointestinal disorders | 5/12 | 3/12 |
| Aspartate aminotransferase increasedInvestigations | 4/12 | 3/12 |
| Abdominal painGastrointestinal disorders | 2/12 | 3/12 |
| BloatingGastrointestinal disorders | 3/12 | 0/12 |
| ConstipationGastrointestinal disorders | 3/12 | 0/12 |
| Alanine aminotransferase increasedInvestigations | 3/12 | 3/12 |
| Alkaline phosphatase increasedInvestigations | 3/12 | 1/12 |
| Back painMusculoskeletal and connective tissue disorders | 1/12 | 3/12 |
| HypertensionVascular disorders | 2/12 | 3/12 |
| Age, Continuous(years) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| Median | 63.8 (42.9 to 77.9) | 69.3 (50.5 to 76.7) | 67.6 (42.9 to 77.9) |
| Sex: Female, Male(Participants) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 6 | 5 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 10 | 11 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| ECOG Performance Status(Participants) | Pembrolizumab & Paricalcitol | Pembrolizumab & Placebo | Total |
|---|---|---|---|
| ECOG 0 | 5 | 4 | 9 |
| ECOG 1 | 7 | 8 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jun 2020, 30 months.
Results were first posted in Dec 2022, 2 years 5 months after primary completion.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's 30 months is below that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paricalcitol
Translational Genomics Research Institute