CompletedNCT05061017Updated Sep 8, 2026Results posted

Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)

A Phase 2 interventional study of Pixatimod and Nivolumab in NSCLC, Metastatic Colorectal Carcinoma and Refractory Melanoma, sponsored by Diwakar Davar. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Diwakar Davar · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 13
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The primary goal of this trial is to assess clinical response to nivolumab and pixatimod, and, nivolumab, pixatimod and cyclophosphamide in three separate patient cohorts. Cohort 1: MSS mCRC in combination with low-dose cyclophosphamide, Cohort 2: PD-1 relapsed/refractory melanoma, and Cohort 3: PD-1 relapsed/refractory NSCLC.

Read the detailed description

Nivolumab is approved by the FDA for the treatment of melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of head/neck, urothelial carcinoma, MSI-H colorectal cancer, hepatocellular carcinoma, gastric carcinoma and gastroesophageal junction (GEJ) cancer.

Pixatimod is an investigational drug that activates the toll-like receptor 9 (TLR9) pathway and is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer.

Cyclophosphamide is approved by the FDA for the treatment of acute lymphoblastic leukemia, acute monocytic leukemia, acute myeloid leukemia, breast cancer, chronic granulocytic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin lymphoma, multiple myeloma, mycosis fungoides, neuroblastoma, non-Hodgkin lymphoma, ovarian cancer, retinoblastoma. Low-dose (immunomodulatory) cyclophosphamide is being studied in combination with various types of immunotherapy including nivolumab and pembrolizumab.

This Phase llA trial hypothesizes that the nivolumab/pixatimod combination in PD-1 relapsed/refractory (R/R) cutaneous melanoma and NSCLC patients will be associated with anti-tumor effects, and that the nivolumab/pixatimod/cyclophosphamide combination in MSS mCRC patients will be associated with anti-tumor effect.

In the 1st stage, 13 patients will be enrolled in cohort 1 while 9 patients each will be enrolled in cohorts 2 and 3. Should the pre-specified efficacy boundary met, further patients will be enrolled to one or more cohorts in 2nd stage. The total enrollment for 1st stage across all 3 cohorts is 31 response-evaluable patients. The total enrollment for both stages across all 3 cohorts is 61 response-evaluable patients.

Conditions studied

NSCLC
Metastatic Colorectal Carcinoma
Refractory Melanoma

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Keywords

melanoma
PD-1/PD-L1 pathway
relapsed metastatic melanoma
refractory metastatic melonma
MSS Metastatic Colorectal Carcinoma
PD-1 R/R NSCLC
PD-1 R/R melanoma
MSS mCRC

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's enrollment of 13 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Diwakar Davar is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

General Inclusion Criteria

Male/female participants who are at least 18 years of age on the day of signing with advanced/ cutaneous melanoma, NSCLC or MSS mCRC who meet the following criteria will be enrolled in this study.
Male participants:
o A male participant must agree to use a during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Female participants:
- 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 (WOCBP);OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

Cohort 1 (MSS mCRC)

MSS is defined as 0-1 allelic shifts among 3-5 tumor microsatellite loci using a PCR-based assay or immunohistochemistry.
Must have received prior therapy with a fluoropyrimidine, oxaliplatin, and irinotecan.
Prior treatment with an /anti-PD-L1 or anti-CTLA-4 antibody is not allowed.
Prior treatment with BRAF/MEK inhibitor therapy (if BRAF mutated) and/or EGFR targeted antibody (if KRAS WT) are allowed.
No more than 5 for metastatic disease.
therapy will count as 1 prior line of therapy if received within the prior 6 months; but if not does not count towards prior line of therapy.
PIV (pan-immune-inflammation) cutoff of 1200 obtained on labs obtained during Screening.

Cohort 2 (PD-1 R/R melanoma)

PD-1 disease as defined as progression on treatment with anti-PD-(L)1 inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
- Receipt of at least 2 doses of an approved or anti-PD-(L)1 inhibitor.
- Demonstrated PD after anti-PD-(L)1 inhibitor as defined by v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression (as defined by the criteria in the sub-point below).
- Progressive disease that has been documented within 12 weeks from the last dose of anti-PD-(L)1 inhibitor.
Progressive disease is determined according to .
This determination is made by the investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.
Subjects who progressed on/within 3 months of adjuvant therapy with anti-PD-(L)1 inhibitor will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.
Prior treatment with an anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody is allowed but not required.
Prior treatment with BRAF/MEK inhibitor therapy (if BRAF mutated) is allowed but not required.
No more than 5 prior lines of therapy.

Cohort 3 (PD-1 R/R NSCLC)

PD-1 refractory disease as defined as progression on treatment with anti-PD-(L)1 inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
- Has received at least 2 doses of an approved or investigational anti-PD-(L)1 inhibitor.
- Has demonstrated PD after anti-PD-(L)1 inhibitor as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression (as defined by the criteria in the sub-point below).
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-(L)1 inhibitor.
Progressive disease is determined according to iRECIST.
This determination is made by the investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.
Subjects who progressed on/within 3 months of adjuvant therapy with anti-PD-(L)1 inhibitor will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.
Prior treatment with an anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody is allowed but not required.
Prior treatment with BRAF/MEK inhibitor therapy (if BRAF mutated) must have received and progressed or have demonstrable intolerance to approved targeted therapy.
Patients with NSCLC with known oncogenic driver (including but not limited to EGFR, ALK, ROS, MET alterations) must have received and progressed past driver-specific therapy.
No more than 5 prior lines of therapy.

Other Criteria

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Have provided newly obtained core or excisional of a tumor lesion not previously irradiated to undergo tumor biopsy (core, punch, incisional or excisional).
o Biopsy must meet minimal sampling criteria.
Have an (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 28 days prior to the date of enrollment.
Adequate organ function. Screening labs obtained within 4 weeks of Cycle 1 day 1
Proteinuria exceeding 1gram in a 24 hour period.
A pan-immune-inflammation (PIV) cutoff of 1200 (obtained on labs during Screening)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion criteria

Exclusion Criteria:

Is currently participating in or has participated in a study of an agent or using an investigational device within 4 weeks of the first dose of treatment.
History of allergy and/or and/or other adverse drug reaction to heparin or other anti-coagulant agents, or to any monoclonal antibody.
Use of heparin (including low-molecular weight heparin and/or fondaparinux) within 2 weeks prior to enrollment.
o Patients who are currently receiving low-molecular weight heparin (or fondaparinux or other heparin product) for therapeutic anticoagulation may be enrolled if they have tested negative for anti-heparin antibodies at Screening.
Has a diagnosis of immunodeficiency, and/or is receiving systemic therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Note: Subjects with disorders of Grade 4 while on prior immunotherapy will be excluded. Subjects who developed autoimmune disorders of Grade ≤ 3 may enroll if the disorder has resolved to Grade ≤1 and the subject has been off systemic steroids at doses >10 mg/d for at least 2 weeks.
Active (i.e., symptomatic or growing) central nervous system (CNS) .
- Note: Subjects with treated and stable are permitted to enroll. Stability for prior treated CNS disease should be assessed on a contrast-enhanced imaging study obtained no sooner than 14 days from data of definitive radiotherapy and/or surgery for CNS disease.
- Note: Subjects with are excluded.
Has a known additional that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone (or is being planned to undergo) potentially curative therapy.
Has a systemic disease that requires systemic pharmacologic doses of corticosteroids greater than 10 mg daily prednisone (or equivalent).
- Note: Subjects who are currently receiving steroids at a dose of ≤10 mg daily do not need to discontinue steroids prior to enrollment.
- Note: Subjects that require topical, ophthalmologic and inhalational steroids are not excluded from the study.
- Note: Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome are not excluded from the study.
- Note: Subjects who require active immunosuppression (greater than steroid dose discussed above) for any reason are excluded from the study.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 26 weeks after the last dose of trial treatment.
Has a known history of (HIV) (HIV 1/2 antibodies).
o Note: Subjects with HIV that is well controlled (undetectable viral load and >200 cells/mm3) on anti-retroviral therapy are permitted to enroll.
Has known active (e.g., HBsAg reactive) or (e.g., HCV RNA [qualitative] is detected.
o Note: Subjects with treated hepatitis B and/or C with no evidence of active infection may be enrolled.
Has a history of significant cardiac disease including but not limited to symptomatic congestive heart failure ( Class III/IV), uncontrolled hypertension (≥150/90mmHg) despite appropriate anti-hypertensive medication (patients with stably controlled hypertension are eligible), unstable angina pectoris or myocardial infarction (≤ 6 months prior to screening), uncontrolled cardiac arrhythmia, clinically significant cardiac valvopathy requiring treatment.
Receipt of (s) within 30 days prior to the first dose of trial treatment.
Other uncontrolled intercurrent illness, including but not limited to, ongoing/active infection, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events and/or compromise the ability of the patient to give written .

Terms in these criteria, in plain language(28)

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

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.

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.

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

iRECIST and mRECIST

Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

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.

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.

0: Fully active, no restrictions.
1: Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2: Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3: Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4: Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

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.

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.

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.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

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.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I: No limits: ordinary activity causes no undue tiredness or breathlessness.
II: Slight limits: comfortable at rest, ordinary activity causes symptoms.
III: Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV: Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

Experimental
Pixatimod (PG545) + Nivolumab + cyclophosphamide - Cohort 1
Cohort 1 (MSS CRC) Pixatimod : 25 mg IV, weekly Nivolumab: 480 mg IV, Q4 weeks cyclophosphamide: 50 mg PO twice daily (Day 1-Day 7; Day 15-Day 21) with a 7-day drug free interval (Day 8-Day 14 and Day 22-Day 28)
Drug: Pixatimod · Drug: Nivolumab · Drug: Cyclophosphamide (low dose)
Experimental
Pixatimod (PG545) + Nivolumab - Cohort 2 & 3
Cohort 2 (PD-1 R/R melanoma) and Cohort 3 (PD-1 R/R NSCLC) Pixatimod : 25 mg IV, weekly Nivolumab: 480 mg IV, Q4 weeks
Drug: Pixatimod · Drug: Nivolumab

Interventions

DrugPixatimod
Pixatimod is an investigational drug that is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer.
Also known as: (PG545)
DrugNivolumab
Nivolumab is approved by the FDA for the treatment of melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of head/neck, urothelial carcinoma, MSI-H colorectal cancer, hepatocellular carcinoma, gastric carcinoma and gastroesophageal junction (GEJ) cancer
Also known as: OPDIVO®
DrugCyclophosphamide (low dose)
Cyclophosphamide is approved by the FDA for the treatment of acute lymphoblastic leukemia, acute monocytic leukemia, acute myeloid leukemia, breast cancer, chronic granulocytic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin lymphoma, multiple myeloma, mycosis fungoides, neuroblastoma, non-Hodgkin lymphoma, ovarian cancer, retinoblastoma. Low-dose (immunomodulatory) cyclophosphamide is being studied in combination with various types of immunotherapy including nivolumab and pembrolizumab

What researchers measure

Primary outcomes

Objective Response Rate (ORR)
Objective Response (rate) will be expressed as the percentage of patients with Complete Response (CR) + Partial Response (PR). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD;Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease is neither \>30% shrinkage nor \>20% growth of tumor.
Time frame: Up to 26 months
Objective Response Rate (ORR) - Combined Study Population
Objective Response (rate) will be expressed as the percentage of patients with Complete Response (CR) + Partial Response (PR). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD;Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease is neither \>30% shrinkage nor \>20% growth of tumor.
Time frame: Up to 26 months

Secondary outcomes

Response Per Immune-related Response Criteria
irCR (Complete Response):Disappearance of non-nodal lesions. All pathologic lymph nodes \<10 mm (2 consecutive measures ≥4 weeks apart); irPR (Partial Response):≥30% decrease from baseline (2 consecutive measures ≥4 weeks apart); irPD (Progressive Disease):≥20% increase from nadir and ≥5mm (2 consecutive measures ≥4 weeks apart); irSD (Stable Disease): Not sufficient decrease for PR, nor sufficient increase for PD
Time frame: Up to 26 months
Response Per Immune-related Response Criteria - Combined Study Population
irCR (Complete Response):Disappearance of non-nodal lesions. All pathologic lymph nodes \<10 mm (2 consecutive measures ≥4 weeks apart); irPR (Partial Response):≥30% decrease from baseline (2 consecutive measures ≥4 weeks apart); irPD (Progressive Disease):≥20% increase from nadir and ≥5mm (2 consecutive measures ≥4 weeks apart); irSD (Stable Disease): Not sufficient decrease for PR, nor sufficient increase for PD; irPR (Progressive Disease): Disappearance of all non-nodal lesions.All pathologic lymph nodes \<10 mm (Non-Target Lesions:Any other than disappearance of all non-nodal lesions and reduction of pathologic lymph nodes \<10 mm). Baseline tumor burden: sum of single diameters (short axis for nodal lesions, longest diameter for other lesions) for target lesions. In subsequent scans, the diameters of new measurable lesions are added to the tumor burden. Re-treatment: ≤5 target lesions (=/≠ original lesions) are selected and a new baseline tumor burden will be established.
Time frame: Up to 26 months
Treatment-related Adverse Events
Distinct number of patients with (all-grade) related adverse events (AE), serious adverse events (SAE) and dose-limiting toxicities (DLT) if any in each cohort. Toxicity events were evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).
Time frame: Up to 26 months
6-month Progression-free Survival (PFS)
Percentage of patients who remain progression-free from the initial date of treatment until 6 months afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 6 months
1-year Progression-free Survival (PFS)
Percentage of patients who remain progression-free from the initial date of treatment until 1 year afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 12 months
2-year Progression-free Survival (PFS)
Percentage of patients who remain progression-free from the initial date of treatment until 2 years afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 24 months
Progression-free Survival (PFS)
Progression-free survival is the time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 27 months
Progression-free Survival (PFS) - Combined Study Population
Percentage of patients with Progression-free survival (measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression)), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 6 months
Progression-free Survival (PFS) - Combined Study Population
Percentage of patients with Progression-free survival (measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression)), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 12 months
Progression-free Survival (PFS) - Combined Study Population
Percentage of patients with Progression-free survival (measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression)), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 24 months
Progression-free Survival (PFS) - Combined Study Population
Progression-free survival is the time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Up to 27 months
6-month Overall Survival (OS)
Percentage of patients that remain alive from the start of treatment until death from any cause at one year.
Time frame: Up to 6 months
1-year Overall Survival (OS)
Percentage of patients that remain alive from the start of treatment until death from any cause at one year.
Time frame: Up to 12 months
2-year Overall Survival (OS)
Percentage of patients that remain alive from the start of treatment until death from any cause at two years.
Time frame: Up to 24 months
Overall Survival (OS) - Combined Study Population
Percentage of patients that remain alive from the start of treatment until death from any cause at 6 months.
Time frame: Up to 6 months
Overall Survival (OS) - Combined Study Population
Percentage of patients that remain alive from the start of treatment until death from any cause at 12 months.
Time frame: Up to 12 months
Overall Survival (OS) - Combined Study Population
Percentage of patients that remain alive from the start of treatment until death from any cause at 24 months.
Time frame: Up to 24 months
Overall Survival (OS) - Combined Study Population
The median length of time (estimated) from the start of treatment that patients remain alive, until death from any cause.
Time frame: Up to 27 months
Change in CD8+ T-cells
Percent change in cellular frequency from baseline in the CD8+ T cell infiltrate and/or NK cell in the tumor and TME in tumor biopsies at treatment timepoints.
Time frame: At baseline, 4 weeks

Results

Posted Mar 7, 2025

Participant flow

Participant flow — Overall Study
Milestone	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 and Cohort 3
Started	5	8
Completed	5	8
Not completed	0	0

Outcome measures

PrimaryObjective Response Rate (ORR)

Objective Response (rate) will be expressed as the percentage of patients with Complete Response (CR) + Partial Response (PR). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD;Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease is neither \>30% shrinkage nor \>20% growth of tumor.

Time frame:: Up to 26 months
Reported as:: Number · percentage of patients

Objective Response Rate (ORR)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
Stable Disease (SD)	40	37.5
Progressive Disease (PD)	60	62.5

Statistical analysis

Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 vs Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 · Fisher Exact · p = 1.0000

SecondaryResponse Per Immune-related Response Criteria

Time frame:: Up to 26 months
Reported as:: Number · percentage of patients

Response Per Immune-related Response Criteria
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
Unknown	0	12.5
iStable Disease	40.0	37.5
iUProgressive Disease	60.0	50.0

Statistical analysis

Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 vs Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 · Fisher Exact · p = 1.0000

SecondaryResponse Per Immune-related Response Criteria - Combined Study Population

irCR (Complete Response):Disappearance of non-nodal lesions. All pathologic lymph nodes \<10 mm (2 consecutive measures ≥4 weeks apart); irPR (Partial Response):≥30% decrease from baseline (2 consecutive measures ≥4 weeks apart); irPD (Progressive Disease):≥20% increase from nadir and ≥5mm (2 consecutive measures ≥4 weeks apart); irSD (Stable Disease): Not sufficient decrease for PR, nor sufficient increase for PD; irPR (Progressive Disease): Disappearance of all non-nodal lesions.All pathologic lymph nodes \<10 mm (Non-Target Lesions:Any other than disappearance of all non-nodal lesions and reduction of pathologic lymph nodes \<10 mm). Baseline tumor burden: sum of single diameters (short axis for nodal lesions, longest diameter for other lesions) for target lesions. In subsequent scans, the diameters of new measurable lesions are added to the tumor burden. Re-treatment: ≤5 target lesions (=/≠ original lesions) are selected and a new baseline tumor burden will be established.

Time frame:: Up to 26 months
Reported as:: Number · percentage of patients

Response Per Immune-related Response Criteria - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3)
Unknown	8
iStable Disease	38
iUProgressive Disease	54

SecondaryTreatment-related Adverse Events

Distinct number of patients with (all-grade) related adverse events (AE), serious adverse events (SAE) and dose-limiting toxicities (DLT) if any in each cohort. Toxicity events were evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).

Time frame:: Up to 26 months
Reported as:: Number · participants

Treatment-related Adverse Events
participants	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
Anemia	1	0
Lymphocyte count decreased	2	0
Neutrophil count decreased	1	0
Alanine aminotransferase increased	0	1
Alkaline phosphatase increased	0	1
Anorexia	0	1
Arthralgia	0	1
Aspartate aminotransferase increased	0	1
Amylase increased	0	1
Fatigue	0	2
Hyperglycemia	0	1
Rash maculo-papular	0	1
Weight loss	0	1

Secondary6-month Progression-free Survival (PFS)

Percentage of patients who remain progression-free from the initial date of treatment until 6 months afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:: Up to 6 months
Reported as:: Number · percentage of patients

6-month Progression-free Survival (PFS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
6-month Progression-free Survival (PFS)	20 (1 to 58)	13 (1 to 42)

Secondary1-year Progression-free Survival (PFS)

Percentage of patients who remain progression-free from the initial date of treatment until 1 year afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:: Up to 12 months
Reported as:: Number · percentage of patients

1-year Progression-free Survival (PFS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
1-year Progression-free Survival (PFS)	0 (NA to NA)	13 (1 to 42)

Secondary2-year Progression-free Survival (PFS)

Percentage of patients who remain progression-free from the initial date of treatment until 2 years afterwards, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:: Up to 24 months
Reported as:: Number · percentage of patients

2-year Progression-free Survival (PFS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
2-year Progression-free Survival (PFS)	0 (NA to NA)	0 (NA to NA)

SecondaryProgression-free Survival (PFS)

Progression-free survival is the time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:: Up to 27 months
Reported as:: Median · months

Progression-free Survival (PFS)
months	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohorts 2 & 3
Progression-free Survival (PFS)	2.00 (1.00 to NA)	2.00 (1.00 to 5.00)

SecondaryProgression-free Survival (PFS) - Combined Study Population

Percentage of patients with Progression-free survival (measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression)), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time frame:: Up to 6 months
Reported as:: Number · percentage of patients

Progression-free Survival (PFS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Progression-free Survival (PFS) - Combined Study Population	15 (2 to 39)

SecondaryProgression-free Survival (PFS) - Combined Study Population

Time frame:: Up to 12 months
Reported as:: Number · percentage of patients

Progression-free Survival (PFS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Progression-free Survival (PFS) - Combined Study Population	15 (2 to 39)

SecondaryProgression-free Survival (PFS) - Combined Study Population

Time frame:: Up to 24 months
Reported as:: Number · percentage of patients

Progression-free Survival (PFS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Progression-free Survival (PFS) - Combined Study Population	0 (NA to NA)

SecondaryProgression-free Survival (PFS) - Combined Study Population

Time frame:: Up to 27 months
Reported as:: Median · months

Progression-free Survival (PFS) - Combined Study Population
months	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Progression-free Survival (PFS) - Combined Study Population	2.00 (1.00 to 4.00)

Secondary6-month Overall Survival (OS)

Percentage of patients that remain alive from the start of treatment until death from any cause at one year.

Time frame:: Up to 6 months
Reported as:: Number · percentage of patients

6-month Overall Survival (OS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
6-month Overall Survival (OS)	80 (20 to 97)	50 (15 to 77)

Secondary1-year Overall Survival (OS)

Percentage of patients that remain alive from the start of treatment until death from any cause at one year.

Time frame:: Up to 12 months
Reported as:: Number · percentage of patients

1-year Overall Survival (OS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
1-year Overall Survival (OS)	0 (NA to NA)	19 (1 to 54)

Secondary2-year Overall Survival (OS)

Percentage of patients that remain alive from the start of treatment until death from any cause at two years.

Time frame:: Up to 24 months
Reported as:: Number · percentage of patients

2-year Overall Survival (OS)
percentage of patients	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
2-year Overall Survival (OS)	0 (NA to NA)	0 (NA to NA)

SecondaryOverall Survival (OS) - Combined Study Population

Percentage of patients that remain alive from the start of treatment until death from any cause at 6 months.

Time frame:: Up to 6 months
Reported as:: Number · percentage of patients

Overall Survival (OS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Overall Survival (OS) - Combined Study Population	62 (31 to 82)

SecondaryOverall Survival (OS) - Combined Study Population

Percentage of patients that remain alive from the start of treatment until death from any cause at 12 months.

Time frame:: Up to 12 months
Reported as:: Number · percentage of patients

Overall Survival (OS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Overall Survival (OS) - Combined Study Population	13 (1 to 43)

SecondaryOverall Survival (OS) - Combined Study Population

Percentage of patients that remain alive from the start of treatment until death from any cause at 24 months.

Time frame:: Up to 24 months
Reported as:: Number · percentage of patients

Overall Survival (OS) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Overall Survival (OS) - Combined Study Population	0 (NA to NA)

SecondaryOverall Survival (OS) - Combined Study Population

The median length of time (estimated) from the start of treatment that patients remain alive, until death from any cause.

Time frame:: Up to 27 months
Reported as:: Median · months

Overall Survival (OS) - Combined Study Population
months	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3)
Overall Survival (OS) - Combined Study Population	11.00 (4.00 to 12.00)

SecondaryChange in CD8+ T-cells

Percent change in cellular frequency from baseline in the CD8+ T cell infiltrate and/or NK cell in the tumor and TME in tumor biopsies at treatment timepoints.

Time frame:: At baseline, 4 weeks

No measurements were reported for this outcome.

PrimaryObjective Response Rate (ORR) - Combined Study Population

Time frame:: Up to 26 months
Reported as:: Number · percentage of patients

Objective Response Rate (ORR) - Combined Study Population
percentage of patients	Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3)
Stable Disease (SD)	38
Progressive Disease (PD)	62

Adverse events

Collected over Adverse Events and Serious Adverse Events occurring up to 26 months from the date start of treatment. All-cause Mortality was assessed from treatment initiation up to 27 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	3/5 (60%)	1/5 (20%)	5/5 (100%)
Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3	6/8 (75%)	3/8 (37.5%)	8/8 (100%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
PneumothoraxRESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	0/5	2/8
Thromboembolic eventVASCULAR DISORDERS	0/5	2/8
Back painMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	1/5	1/8
Muscle weakness lower limbMUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	1/5	1/8
Sinus tachycardiaCARDIAC DISORDERS	0/5	1/8
VertigoEAR AND LABYRINTH DISORDERS	0/5	1/8
NauseaGASTROINTESTINAL DISORDERS	0/5	1/8
FatigueGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	0/5	1/8
Alanine aminotransferase increasedINVESTIGATIONS	0/5	1/8
DizzinessNERVOUS SYSTEM DISORDERS	0/5	1/8

Most frequent other events

Showing 10 of 80

Most frequent other events
Event	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3
Activated partial thromboplastin time prolongedINVESTIGATIONS	4/5	2/8
AnemiaBLOOD AND LYMPHATIC SYSTEM DISORDERS	2/5	5/8
HypertriglyceridemiaMETABOLISM AND NUTRITION DISORDERS	3/5	3/8
HyponatremiaMETABOLISM AND NUTRITION DISORDERS	3/5	4/8
FatigueGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	2/5	4/8
Infusion related reactionINJURY, POISONING AND PROCEDURAL COMPLICATIONS	0/5	4/8
Sinus tachycardiaCARDIAC DISORDERS	2/5	0/8
DiarrheaGASTROINTESTINAL DISORDERS	2/5	3/8
Alkaline phosphatase increasedINVESTIGATIONS	2/5	1/8
Blood lactate dehydrogenase increasedINVESTIGATIONS	2/5	2/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & 3	Total
Mean	58.00 ± 13.45	71.75 ± 8.26	66.46 ± 12.19

Sex: Female, Male
Sex: Female, Male(Participants)	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & 3	Total
Female	3	4	7
Male	2	4	6

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & 3	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	4	7	11
Unknown or Not Reported	1	1	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1	Pixatimod (PG545) + Nivolumab - Cohort 2 & 3	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	0	0	0
White	3	7	10
More than one race	0	0	0
Unknown or Not Reported	1	1	2

Study locations

1 site

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232, United States

References and documents

Publications

Lemech C, Dredge K, Bampton D, Hammond E, Clouston A, Waterhouse NJ, Stanley AC, Leveque-El Mouttie L, Chojnowski GM, Haydon A, Pavlakis N, Burge M, Brown MP, Goldstein D. Phase Ib open-label, multicenter study of pixatimod, an activator of TLR9, in combination with nivolumab in subjects with microsatellite-stable metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma and other solid tumors. J Immunother Cancer. 2023 Jan;11(1):e006136. doi: 10.1136/jitc-2022-006136. PubMed 36634920 ↗

Study documents

Protocol and statistical analysis plan ↗ · Feb 23, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Feb 2024, 25 months.

Results were first posted in Mar 2025, 1 year 1 month after primary completion.

Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's 25 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 20, 2021
First posted: Sep 29, 2021
StartActual: Dec 9, 2021
Primary completionActual: Feb 5, 2024
CompletionActual: Mar 18, 2024
Results first posted: Mar 7, 2025
Last update: Sep 8, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05061017
Lead sponsor: Diwakar Davar
Collaborators: Aculeus Therapeutics
Responsible party: Diwakar Davar (Associate Professor of Medicine, University of Pittsburgh) — Sponsor-investigator
First posted: Sep 29, 2021
Start date: Dec 9, 2021
Primary completion: Feb 5, 2024
Completion: Mar 18, 2024
Results posted: Mar 7, 2025
Last update: Sep 8, 2026

Study contacts

Diwakar Davar, MD

principal investigator · UPMC Hillman Cancer Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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