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Non Hodgkin LymphomaPhase 1/2NCT06767956

Golcadomide and Nivolumab in Patients With Non-Hodgkin Lymphoma With Refractory Disease After Chimeric Antigen T-cell Therapy

A Phase 1/2 study testing GOLCADOMIDE and Nivolumab in people with Non Hodgkin Lymphoma, run by University of Pittsburgh.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this combined phase I/II, open label, single arm trial to study, the safety and efficacy of combination Golcadomide and nivolumab in patients with non-Hodgkin lymphoma (NHL) who have experienced refractory/residual disease, at or after 30 days of receiving chimeric antigen T-cell (CAR-T) therapy will be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
GOLCADOMIDE and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2025to 30 Apr 2028
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed informed consent and willingness to comply with all study requirements for the duration of the study.
  • Patients 18 years of age or older.
  • Patients must have histologically confirmed high-grade large B-cell lymphoma such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL grade 3B), primary mediastinal B-cell lymphoma (PMBCL). Patient with transformation from indolent to large cell lymphoma will be allowed to enroll in the study.
  • Presence of FDG avid, radiographically measurable disease (Deauville 4-5) per Lugano 2014 response criteria which will include patients with metabolic partial response (PR), stable disease (SD), and progressive disease (PD), as assessed by the investigator.
  • Patients who received FDA-approved CD19-directed CAR T-cell product(s) (exclusive of any investigational CAR T-cell products).
  • Evidence of measurable residual disease 30 days and up to 1 year after receiving CAR-T therapy. Screening visit should be performed no later than day 365 after CAR-T infusion.
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  • Eastern Cooperative Oncology group ECOG performance status ≤ 2.
  • Patients must have adequate organ and marrow function as defined in the protocol at the time of consent. Abnormalities reasonably attributed to underlying lymphoma will be allowed (e.g. anemia due to marrow involvement or LFT elevation due to metastatic involvement)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible.
  • For patients with evidence of chronic hepatitis virus infection (HBV or HCV), the viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with CNS relapse (as an extension of systemic disease) are eligible, as determined by the investigator.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The malignancy should not be progressing or requiring active systemic treatment within the past year.
  • Patients with known history or current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and may require an echocardiogram at the discretion of the investigator. To be eligible for this trial, patients should be class II, stage B or better.
  • Females of childbearing potential (FCBP) must have a negative pregnancy test during screening.
  • All subjects of childbearing potential must agree to use contraceptive methods (hormonal or barrier method of birth control; abstinence) for the duration of the study and for at least 28 days after the last dose of golcadomide. Should a woman become pregnant while she or her partner is participating in this study, she should inform her treating physician and discontinue therapy immediately. Pregnancies (both those of female patients and female partners of male patients) are reported in the same manner as SAEs within 24 hours of the Investigator's knowledge.
  • Ability to take oral medication and be willing to adhere to the golcadomide and nivolumab regimen.

Who cannot join

  • Treatment with any intervening anti-cancer therapies (other than palliative radiation) following CAR-T therapy. This study is intended to be the first treatment of residual disease after CAR-T therapy.
  • Patients who have not recovered from AEs (other than hematologic) of prior anti-neoplastic therapy (i.e., have residual toxicities > Grade 1) for the exception of alopecia, that require active management.
  • Hypersensitivity reaction to any of the study drugs or their derivatives.
  • Medical or psychiatric co-morbidities that in the opinion of the treating physician may compromise either compliance with or tolerance of study drugs.
  • Patients with GI malabsorption that may compromise absorption of oral golcadomide.
  • Presence of active autoimmune disease.
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  • Patients requiring strong CYP3A inducers or inhibitors will be excluded. Note:
  • Avoid coadministration of moderate CYP3A inhibitors and
  • Avoid coadministration of moderate CYP3A inducers until more information regarding the potential DDI risk is available.
  • Patients previously taking strong CYP3A inhibitors/inducers will require a washout period of at least 14 days or 5 half-lives, whichever is shorter, prior to the initiation of study treatment.
  • Currently breastfeeding females.

About this study

Official title: Phase I/II Study of Combination Golcadomide and Nivolumab in Patients With Non-Hodgkin Lymphoma With Refractory Disease After Chimeric Antigen T-cell Therapy

In this combined phase I/II, open label, single arm trial to study, the safety and efficacy of combination Golcadomide and nivolumab in patients with non-Hodgkin lymphoma (NHL) who have experienced refractory/residual disease, at or after 30 days of receiving chimeric antigen T-cell (CAR-T) therapy will be studied. A dose escalation phase will be followed by a dose expansion design.

Read the detailed description

Non-Hodgkin lymphoma (NHL) is a diverse group of lymphoid neoplasms affecting 80,470 new cases in the USA every year.1 Among the common types of NHL, diffuse large B-cell lymphoma (DLBCL) carries a five-year survival of 64.4% (SEER). Prognosis depends on disease specific factors such as stage and extent of spread, in addition to patient specific factors, such as age and performance status. Prior studies suggest that anti-PD-1 therapy may be effective in this population, especially if there is a way to further sensitize tumor cells to anti-PD-1 therapy to reduce T-cell exhaustion and increase inflammatory cytokines. Exposure to CELMoDs in addition to anti-PD1 therapy following CAR-T relapse may lead to deeper and more durable responses through re-expansion of CAR-T cells and modulation of tumor microenvironment (TME). This trial hypothesizes that combination Golcadomide at the selected dose and nivolumab at standard dosing will be safe and effective and that an overall response rate 45% or greater with a maximum dose-limiting toxicity (DLT) rate of 25% would be sufficient to warrant further interest in this combination in patients who have refractory NHL after 30 days of receiving therapy.

Being tested
GOLCADOMIDE, Nivolumab
Keywords
refractory disease, chimeric antigen, B cell lymphomas, Cereblon E3 Ligase Modulators (CELMoD), immunomodulatory drugs (IMiD), tumor microenvironment (TME)
Medical subject headings
Lymphoma, Non-Hodgkin, Disease, Lymphoma, B-Cell

What participants receive

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

  • GOLCADOMIDEDrug

    Also called Golcadomide (GOLCA; CC-99282)

    Golcadomide (GOLCA, CC-99282) is an oral cereblon E3 ligase modulator (CELMoD®) agent with immunomodulatory and tumor cell-autonomous activities. It is a modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities.

  • NivolumabDrug

    Nivolumab is an immune checkpoint inhibitor targeted therapy drug that blocks the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system, boosting the immune system's response.

Study groups in NCT06767956
Study groupRoleWhat they receive
GOLCADOMIDE + Nivolumab 480 mg IVExperimentalGOLCADOMIDE PO QD (Day 1-14) Nivolumab 480 mg IV (Q4 wk) Continue up to 24 cycles or until intolerable toxicity or disease progression
Receives: Drug: GOLCADOMIDE; Drug: Nivolumab

What is being measured

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

  1. Maximum tolerated dose (MTD) / Recommended Phase 2 dose (RP2D)

    The number and type of Dose Limiting Toxicities experienced during the first two cycles of treatment will be observed and assessed (per NCI-CTCAE v5.0) to determine the Maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of golcadomide combined with standard dose nivolumab in participants with NHL who experienced disease progression or relapse after receiving CAR-T therapy as determined.

    Measured: Up to 56 days from start of treatment

  2. Lugano Response Evaluation

    Occurrence of partial response or better (objective response) per the Lugano PET-CT treatment response criteria. The Lugano classification (2014) is a lymphoma staging system that includes response based on CT evaluation. Scoring: (1)=no uptake or no residual uptake (when used interim), (2)=slight uptake, but below blood pool (mediastinum), (3)=uptake above mediastinal, but below or equal to uptake in the liver, (4)=uptake slightly to moderately higher than liver, (5)=markedly increased uptake or any new lesion (on response evaluation). Complete metabolic response (CMR) (score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass. Partial metabolic response (PMR) (score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size), or stable disease or no metabolic response (score of 4 or 5 with no obvious change in FDG uptake)

    Measured: Up to 36 months

Secondary outcomes (4)

  1. Adverse Events and Serious Adverse Events (Phase l - Dose Escalation)

    Incidence of severity of adverse events and serious adverse events at least possibly related to trial treatment, per NCI-CTCAE v5.0.

    Measured: Up to 56 days from start of treatment

  2. Adverse Events and Serious Adverse Events (Phase ll - Dose Expansion)

    Incidence of severity of adverse events and serious adverse events at least possibly related to trial treatment, per NCI-CTCAE v5.0.

    Measured: Up to 36 months

  3. Preliminary Efficacy per Lugano Response Evaluation

    Occurrence of partial response or better (objective response) per the Lugano PET-CT treatment response criteria. The Lugano classification (2014) is a lymphoma staging system that includes response based on CT evaluation. Scoring: (1)=no uptake or no residual uptake (when used interim), (2)=slight uptake, but below blood pool (mediastinum), (3)=uptake above mediastinal, but below or equal to uptake in the liver, (4)=uptake slightly to moderately higher than liver, (5)=markedly increased uptake or any new lesion (on response evaluation). Complete metabolic response (CMR) (score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass. Partial metabolic response (PMR) (score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size), or stable disease or no metabolic response (score of 4 or 5 with no obvious change in FDG uptake)

    Measured: Up to 26 months

  4. Progression-free survival (PFS)

    Median time patients do not experience disease progression per Lugano classification (2014). Lugano criteria is a staging system including CT response evaluation. Scoring: (1)=no uptake or no residual uptake (when used interim),(2)=slight uptake, but below blood pool (mediastinum),(3)=uptake above mediastinal, but below or equal to uptake in the liver,(4)=uptake slightly to moderately higher than liver,(5)=markedly increased uptake or any new lesion (on response evaluation). Disease progression score=4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or new FDG-avid foci consistent with lymphoma). Complete metabolic response (CMR) (score=1, 2 or 3 in nodal or extranodal sites with or without a residual mass, partial metabolic response (PMR) (score= 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size), or stable disease or no metabolic response (score=4 or 5 with no obvious change in FDG uptake)

    Measured: Up to 36 months

Timeline

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

  1. First posted10 Jan 2025
  2. Study start30 Jun 2025 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Why it stopped: IND Sponsor-Investigator left institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Escalation of golcadomide combined with nivolumab at standard dosing will follow a standard 3+3 design with sequential cohorts of 3 participants. The first cohort will be treated at the 0.2 mg (14 days) dose level. Dose levels for Golcadomide: * Dose level 0: 0.1 mg (14 days) * Dose level 1: 0.2 mg (14 days) (starting dose) * Dose level 2: 0.4 mg (14 days)
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767956
Sponsor's protocol ID
HCC 23-161
Status last verified
May 2025
First submitted
5 Jan 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GOLCADOMIDE and Nivolumab in people with Non Hodgkin Lymphoma, run by University of Pittsburgh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

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

What does the primary outcome measure?

Maximum tolerated dose (MTD) / Recommended Phase 2 dose (RP2D) (time frame: Up to 56 days from start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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